DRUGS & COSMETICS ACT 1940 (2019)- A CRITICAL ANALYSIS

 

Globally, every country is the victim of substandard or spurious drugs, which result in life threatening issues, financial loss of consumer and manufacturer and loss in trust on health system. With a population of more than 1.24 billion, right to health is a fundamental right in India and has been recognized in the national constitution and statutory laws as well as in international laws. Globally, about 2 billion people, one third of the global population lack access to essential medicines

As medicine are life saving entities and thus are more essential for the treatment, while they account for 20-60% of care cost and 50-90% of this cost is being paid by the patient, particularly in low and middle income countries. India is a developing country where more than 40% of the population survives on less than US $1 a day and if a patient needs medicines he has to pay more than half of this. There are some schemes by Indian Government for distribution of free generic medicines for certain categories of patients

However, people accept, prefer and buy counterfeit or substandard products over genuine or branded products due their cheap price, easy accessibility and availability in the market. Consumer does not know about the manufacturer or the quality of the product and many time they are unaware of expired, degraded or substandard products which ultimately results in failure of the treatment and with antibiotics this lead to antimicrobial resistance.Substandard product arises correspondingly due to lack of expertise, unfair manufacturing practices or insubstantial infrastructure whereas counterfeit is the product of black marketer.

The problem of poor quality is already very serious and steadily growing and is likely to cause much more damage in the near future. Unbelievably, 0.20 to 0.30 million people die every year in China just because of counterfeit and substandard drug product. No such data is available in India, yet many patients are dying every year. According to a report revealed by International Policy Network, globally 0.70 million deaths were reported for malaria and tuberculosis because of counterfeit drugs. On one side, India extensively interacts with the African countries in providing quality medicine at affordable prices, while on other side predictive blames were imposed on India and China for exporting the fake or substandard quality of antimalarial, antibiotics and contraceptives drug product to Uganda and Tanzania. In turn, India and China is denying for such blames. Nevertheless, in 2009, 24 136 samples of 62 brands of drugs product were collected in a nationwide survey to find those products which are covertly manufactured and thus to explore the extent of spurious drug in India. Samples were drawn from over 100 pharmacy outlets from various regions of India, which were belong to nine therapeutic categories of 30 manufacturers.

 Survey affirmed that only 11 products (0.046%) were spurious. Supplementary information revealed by the State Drugs Control Departments declared 1146 (4.75%) products were of substandard quality. In 2008, a pilot study performed in two major cities of India, Delhi and Chennai to explore the extent of substandard and counterfeit drugs available in market, under which it was estimated that 12 and 5% samples from Delhi and Chennai, respectively, were of substandard quality.  In 2007-08 maximum instances were from Maharashtra and in 2008-09 Kerala was the leading manufacturer of the spurious and substandard drugs.In 2007 four deaths were reported in Maharashtra related to spurious drugs. While more serious results came in news when it was reported that 300 infant died in 2012 in Kashmir because of ceftriaxone substandard quality product which was used to treat pneumonia

 

In general poor quality drug are the spurious/falsely-labeled/falsified/counterfeit (SFFC) drugs that can cause treatment failure or even death. Accordingly, International medical products anti counterfeiting taskforce (IMPACT) of World Health Organization (WHO) defines SFFC medicines as “medicines which are deliberately and fraudulently mislabelled with respect to identity and/or source, and also which may include products with correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging”.

For minimizing spurious/falsely-labelled/falsified/counterfeit drugs or not of standard quality drugs, there is urgent requirement of more stringent regulation and legal action against the problem.

OBJECTIVES OF THE ACT

1. To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.
2. Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.
3. To prevent substandard in drugs, presumably for maintaining high standards of medical treatment.
4. To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
5. To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs and cosmetics.

SALIENT FEATURES

1. Maximum penalty life imprisonment and fine of Rs. 10 lakhs or 3 times the value of the confiscated goods, whichever is more.
2. Besides officers from the Drug Controller’s Office, other gazette officers also authorized to launch prosecution under the Act
3. Some of the offences cognizable and non-bailable
4. Specially designated courts for trial of offences covered under the Act
5. Provision for compounding of minor offences.

 

DEFINATIONS

Drugs

·         all medicines for internal or external use of human beings or animals

·         and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals,

·         including preparations applied on human body for the purpose of repelling insects like mosquitoes.

·         Such substance intended to be used for destruction of vermin or insects which cause disease in the human beings or animals.

·         All the substances intended for use as components of drug including empty gelatin capsule and,

·         Such devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.

A list of 37 devices has been drawn up and it includes syringes, needles, stents, catheters, intraocular lenses, intravenous cannulae, prosthetic replacements, ligatures, sutures, staplers, condoms, blood bags, nebulizers, blood pressure monitoring machines and digital thermometers. The MoHFW has specified that all such devices including instruments, apparatus, appliances, implants or other articles, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specifically on human beings or animals, will be considered for this purpose.

 

Cosmetic

Means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic

Ayurvedic, Siddha, or Unani drug

Includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani systems of medicine, specified in the First Schedule.

Misbranded drugs

 A drug shall be deemed to be misbranded

·         if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or

·          if it is not labelled in the prescribed manner; or

·          if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

 Misbranded cosmetic

 A cosmetic shall be deemed to be misbranded

·         If it contains a colour which is not prescribed; or

·         If it is not labelled in a prescribed manner; or

·         If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

Adulterated drugs

A drug shall be deemed to be adulterated

·         If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

·         If it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

·         If its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

·         If it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

·         If it contains any harmful or toxic substance which may render it injurious to health; or

·         If any substance has been mixed therewith so as to reduce its quality or strength. e.g. supply of cheap cottonseed oil in stead of olive oil

 

Supirious Drugs

As per section 17(B) of Drugs and Cosmetics Act, 1940 a Drug shall be deemed to be Spurious

·         if it is manufactured under a name which belongs to another Drug;

·         if it is an imitation of, or is a substitute for, another Drug or resembles another Drug in a manner likely to deceive or bears upon it or upon its label or container the name of another Drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other Drug; or

·         if the label or container bears the name of an individual or company purporting to be the manufacturer of the Drug ,which individual or company is fictitious or does not exist;

·         or if it has been substituted wholly or in part by another Drug or substance; or

·         If it purports to be the product of a manufacturer of whom it is not truly a product.

Spurious cosmetic

A cosmetic shall be deemed to be spurious if

·         If it is imported under the name which belongs to another cosmetic; or

·         If it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or

·         If the label or the container bears the name of an individual or company purporting to be the manufacturer of the cosmetic, which individual or company is fictitious or does not exist; or

·         If it purports to be the product of a manufacturer of whom it is not truly a product.

 

New drug

Shall mean and include

·         A new substance of chemical, biological or biotechnological origin, in bulk or prepared dosage form; used for prevention, diagnosis, or treatment of disease in man or animals; which except during local clinical, trials, has not been used in the country to any significant extent and which has not been recognized in the country as effective and safe for the proposed claims.

·         A drug already approved by the licensing authority for certain claims which is now proposed to be marketed with modified or new claims, namely indications, dosage form (including sustained release dosage form) and route of administration.

·         A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz indications, dosage, form (including sustained release dosage form) and route of admin.

·         A new drug shall continue to be considered as new drug for a period of 4 yrs from the date of its first approval or inclusion in the I. P. whichever is earlier

 

Not Of Standard Quality Drug

For the purpose of Drug Survey, a Drug is considered to be Not of Standard Quality if it does not comply with the Standards of Quality as specified in Section 16 of the Drugs and Cosmetics Act, 1940 read with Second schedule of the said Act

Generic and Brand Name:

For the purpose of this survey generic name of a Drug is the name given under pharmacopoeia whereas brand name is the trade name selected by the manufacturing company.For example, Paracetamol is the generic name whereas Calpol and Crocin are the two popular brand names given by the manufacturers.

PHARMACOPOEIA- An official publication containing a list of medicinal drugs with their effects and directions for their use

Retail Outlets:

 For the purpose of this study, Retail Outlets are those that have been licensed by respective State Licensing Authorities to sell Drugs.

Ports/Notified Ports:

Refers to Ports notified by the Government for import of Drugs.

Patent/Proprietary Drugs

·         In relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books

·         in relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in this behalf by the Central Government

 

CATEGORIES OF DRUGS

With the 2008 amendment of D and C act, Indian drug regulatory authority that is Central Drugs Standard Control Organization (CDSCO) has categorised not of standard quality (NSQ) products in three categories A, B and C that is helpful in categorising the products during quality evaluation

 

Category A

 It incorporates spurious and adulterated drug products; which conceal the real identity of the product or formulation and be similar to some well-known brand

These products may or may not contain active ingredients and generally manufactured by unlicensed units.

Category B

It includes grossly substandard drugs in which product fails the disintegration or dissolution test and where active ingredient assay get below 70%

In case of preparation, failing sterility, inappropriate toxicity, and fungus presence in any liquid preparation hold such products in this substandard category.

Category C

involved products with minor defects like emulsion cracking, change in formulation colour, small variation in net content, sedimentation in clear liquid preparation, failing of weight variation test, spot or discolouration on product, uneven coating, and presence of foreign matter and labelling errors

 

CLASSES OF DRUGS PROHIBITED TO BE SOLD

·         Misbranded, spurious, adulterated and drugs not of standard quality

·         Patent/Proprietary drugs with undisclosed formula

·         Schedule-J drugs

·         Expired drugs

SCHEDULE J

Schedule J contains a list of diseases and ailments which a drug may not claim to prevent or cure. Under Rule 106 of the Drugs and Cosmetics Act, 1940, a drug cannot make claims to treat or prevent any of the diseases or reform the conditions listed. For example AIDS, CANCER, BLINDNESS, DIABETES, FAIRNESS OF SKIN, GLUCOMA HEIGHT IMPROVEMENT, PARKINSON, CHANGE OF FOETAL SEX.

 

CLASSES OF DRUGS PROHIBITED TO BE MANUFACTURED

·         Drug not of standard quality or misbranded, adulterated or spurious.

·         Patent medicine.

·         Drugs in Sch-J

·         Risky to animal/human.

·         Marketed in packing not exceeding 100 unit dose, 300ml of oral liquid, 5ml- injection

·         Manufacture of drugs other than in Sch-C/C1

·         Adequate facility for testing, separating from manufacturing

·         Premises should comply with schedule ‘M’.

·         Adequate storage facility.

·         Furnish data of stability.

·         Maintain the inspection book.

·         Maintain reference samples from each batch.

 

CLASSES OF DRUGS PROHIBITED TO BE IMPORTED

·         Misbranded drugs

·         Drugs of substandard quality

·         Drugs claiming to cure diseases specified in Sch-J

·         adulterated drugs

·         Spurious drugs

·         Drugs whose manufacture, sale/distribution are prohibited in original country,

·         Patent/Proprietary medicines whose true formula is not disclosed.

 

 

 

AUTHORITIES

Advisory

·         Drugs Technical Advisory Board-DTAB

·         Drugs Consultative Committee-D.C.C.

Analytical

·         Central Drugs Laboratory – CDL

·         Drug Control Laboratory in states

·         Government Analysts

Executives

·         Licensing authorities

·         Controlling authorities

·         Drug Inspectors

 

DTAB -The Drug Technical Advisory Board - Section 5

·         The Board has been set up by the Central Govt to advise it and the State Governments of technical matters arising out of the administration of this Act and for carrying out other functions assigned to it by this Act.

·         It consists of

-        Director General of Health Services as Chairman, the Drugs Controller,

-        Directors of Central Drugs Laboratory,

-        Central Research Institute, NRI,

-        Medical Council of India,

-        Pharmacy Council of India,

-        Nominees of the Central Government,

-        Pharmacy teachers,

-        representatives of pharmaceutical industry, etc.

·         The Board may make Bye-laws for its own regulation and function through Sub-committee.

The Drugs Consultative Committee -section 7

this has been constituted by the Central Government as an advisory committee to advise the Central, state govt and the Board on any matter pending to secure uniformity in the administration of this Act.

Constitution:

·         Two representatives of the Central Government

·         One representative of each State Government

Functions:

·         To advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of this Act.

·         The Drugs Consultative Committee shall meet when require.

·         Has power to regulate its own procedure.

 

Central Drugs Laboratory

This is established by the Central Government under section 6  

Rules provide for the procedure tor admission of samples of drugs or cosmetics for analysis or test, making of reports, fees to be paid, etc.

Functions:

·         Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts.

·         Collection, storage and distribution of internal standards.

·         Preparation of reference standards and their maintenance.

·         Maintenance of microbial cultures.

·         Any other duties entrusted by Central Government.

Drug Control Laboratories in the State

Every state has a laboratory for the analysis & testing of the drugs & cosmetics manufactured or sold in that particular area. n Samples sent by D.I. are analyzed by such laboratories. Also analyzed the drugs sent by any person or purchaser on payment of necessary fee.

 

Medical Devices Technical Advisory Board

Added by 2015 amendment

To advice the apex drug regulator, Central Drugs Standard Control Organisation (CDSCO) on matters related to the regulation and implementation of medical devices, the Union Health Ministry has recently constituted a special committee under the name Medical Devices Technical Advisory Group (MDTAG), The MDTAG committee will be chaired by Drugs Controller General of India (DCGI) while the Deputy Drugs Controller of India, Medical Devices Division, CDSCO has been appointed as the Member Secretary.
esides the Chairperson and the Member Secretary, 22 other members constitute the committee from various departments containing representatives from the following departments; Department of Science and Technology(DST) National Institute of Biologicals (NIB) Indian Council of Medical Research (ICMR) Atomic Energy Regulatory Board (AERB) Defence Research and Development Organisation (DRDO) Bureau of Indian Standards (BIS) IIT, New Delhi Department of Electronics and Information Technology (DEITY) National Health Systems Resource Centre (NHSRC) Association of Diagnostics Manufacturers of India (ADMI) Association of Indian Medical Device Industry (AIMED) Federation of Indian Chambers of Commerce and Industry (FICCI) American Chamber of Commerce in India (AMCHAM India) as its members.

Bringing majority of medical devices under regulation is high on the agenda of the ministry in the second tenure of the Modi government with some incidents of adverse reactions and impacts coming to light with the use of medical devices. "The aim is to strengthen the regulations to make medical device companies accountable for quality and safety of their products," a senior official told PTI. Recently, global pharma giant Johnson and Johnson (JnJ) was reportedly directed to pay compensation to the patients who received faulty hip implants made by the firm.

CONTROLLING AUTHORITY UNDER THE ACT

All Inspectors appointed by the Central Government shall be under the control of an officer
appointed in this behalf by the Central government and State Government

 

GOVERNMENT ANALYST- Section 20

·         Analyze or test samples of drugs/cosmetics sent to him by inspectors or other persons under the act and to furnish reports of the results of test or analysis.

·         Forward to Government from time to time, reports giving the results of analysis works and research.

Qualifications

 These officers are appointed by the Central or State Government and perform the duties.

·         Persons having Qualification for appointments as government as governmental analysis for drugs;

·         Must have a degree in Medicine/Ayurveda/Sidha/Unani system and not less than 3 year post-graduate experience in the analysis of drug.

Duties

·         The Government Analyst shall cause to be analysed or tested such samples or drugs
and cosmetics as may be sent to him by Inspectors.

·         A Government Analyst shall from time to time forward reports to the Government
giving the result of analytical work and research with a view to their publication.

Reports of Government Analysts

The Government Analyst to whom a sample of any drug 3 [or cosmetic] has been submitted for test or analysis shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.

 The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken and shall retain the third copy for use in any prosecution in respect of the sample.

Any document purporting to be a report signed by a Government Analyst shall be evidence to the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report.

 The cost of a test or analysis made by the Central Drugs Laboratory shall be paid by the complainant or accused as the Court shall direct

 

INSPECTOR SECTION 21

The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or State Government, as the case may be.

The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or  classes of drugs or cosmetics or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed.

Qualifications

·         A graduate in pharmacy or pharmaceutical sciences or medicine with specialization in Clinical Pharmacology or Microbiology of a recognized university; Provided that for the purpose of Inspection of Manufacture of substances specified in Schedule C, a person appointed as a Drug Inspector should have,

·         Not less than 18 months experience in the manufacture of atleast one of the substances specified in Schedule C; or

·         Not less than 18 months experience in testing of atleast one of the substances specified in Schedule C in a approved laboratory; or

·         Not less than 3 years experience in the inspection of firms manufacturing any of the substances specified in Schedule C during the course of their services as the Drug Inspectors Qualifications for Drug Inspectors

 

 Powers of Inspectors

Inspect:

·         Any premises wherein any drug or cosmetic is being manufactured. And also he may inspect the means employed for standardizing and testing the drug or cosmetic

·         Any premises wherein any drug or cosmetic is being sold or stocked or exhibited or offered for sale or distributed

Take samples of any drug or cosmetic:

·         which is being manufactured or being sold or is stocked or offered for sale or exhibited or being distributed

·         from any person conveying, delivering or preparing to deliver any drug or cosmetic to a purchaser or a consignee

 Search

·         any person in connection with the offence under this chapter at all reasonable times

·         Enter and search at all reasonable times, any place or premises in which he has reason to believe that an offence is being committed or has been committed

·         Stop and search any vehicle or conveyance which he has reason to believe, used for carrying any drug or cosmetic in respect of which offence has been or is being committed

·         Give order in writing to the person in possession of drug or cosmetic in respect of which offence has been committed not to dispose stock of such drug or cosmetic for a specified period not exceeding twenty days or unless the defect may be removed by the possessor of the drug or cosmetic, and may seize the stock of such drug or cosmetic or any substance /article employed for commission of offence Powers Of Drug Inspectors

Examine

·         any record, register, document, or any other material object found while exercising above powers and seize the same if he has reason to believe that it is an evidence of commission of an offence under the Act

·          Exercise any other powers as may be necessary, for carrying out the purpose of this Act and the rules made there under Powers Of Drug Inspectors

 In relation to sale of drugs and cosmetics:

·         To inspect atleast once a year all establishments licensed for sale of drugs in the area assigned to him and to satisfy himself whether the conditions of the licences are observed or not

·         If he thinks necessary to obtain and send samples of imported drugs and cosmetics for test or analysis, which are being sold or stocked in contravention of the provisions of this Act

·         To investigate any complaint made in writing to him

·         To institute prosecutions in case of the breach of the Act and Rules

·         To maintain the records relating to all inspections and actions taken by him and to submit copies of such records to the controlling authority

·         To make inquiries and inspections regarding the sale of drugs in contravention of the Act

·         To detain the imported packages, if he suspects to contain drugs the import of which is prohibited Duties of Drug Inspectors

In relation to manufacture of drugs and cosmetics:

·         To inspect atleast once a year all premises licensed for manufacture of drugs in the area assigned to him and to satisfy himself whether the conditions of the licences and provisions of the Act and Rules are observed or not

·         To inspect premises licensed for mfg of drugs specified in Schedule C and C(1) and to observe process of manufacture, means employed for standardization and testing of drugs, storage conditions, qualifications of technical staff employed and all other details of construction, location, administration of establishment etc. which are likely to affect potency or purity of product.

·         To send after each inspection, a detailed report of inspection to controlling authority with details of conditions of licence and provisions of the Act and Rules being observed and those not observed.

·         To take samples of drugs manufactured on premises and send them for test or analysis

·         To check all records and registers required to be maintained under rules.

·         To institute prosecutions for breaches of Act Duties of Drug Inspectors

 For taking samples of drug and dispatching them to laboratory:

·         Where an Inspector takes any sample of a drug or cosmetic, he shall tender the fair price thereof and may require a written acknowledgment thereof

·         Where the price is refused, he shall tender a receipt thereof in the prescribed form.

·         Where an Inspector takes a sample of a drug or cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he wilfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked.

·         Where the sample is taken from premises whereon the drug or cosmetic is being manufactured, it shall be necessary to divide the sample into three portions only Procedure Of Inspectors

 

Penalty for obstructing Inspector
If any person wilfully obstruct an Inspector in the exercise of the powers conformed upon him or refuse to produce any record, register or any other document when required or any document when required, he shall be punishable with imprisonment (jail) up to 3 year or with fine or with both.

 

Law relating to sea and customs

The Customs Collector and other officers authorized in this behalf by the Central Government may detain any imported packages which he suspects to contain any drug or cosmetic the import of which is prohibited by this Act and report such detention to the Drugs Controller, India and if found necessary can forward any package or sample to CDL for analysis.

 

Licensing Authority
Qualification:

·         All member should be Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with Specialization in Clinical pharmacology or microbiology.

·         5 year Experience in manufacture or testing of drugs.

Duties:

·         To inspect all establishments licensed for the sale of drugs within the area assigned to him;

·         To satisfy himself that the conditions of the licences are being observed;

·         To procure and send for test or analysis, if necessary, imported packages.

·         To investigate any complaint

·         To maintain a record of all inspections made and action taken by him in the performance of his duties,

·         To make such enquiries and inspections as may be necessary to detect the sale of drugs in
contravention to the Act;

 

IMPORT OF DRUGS AND COSMETICS

Classes of drugs prohibited to Import

·         Any drug which is not of standard quality.

·         Any misbranded, spurious or adulterated drug

·         Any misbranded or spurious cosmetic

·         Any drug or cosmetics which require import license & if imported without such license.

·         Any patent or proprietary medicine, the true formula or list of active ingredients with their true quantities, is not displayed on the label or container in a prescribed manner.

·         Any cosmetics containing any such ingredient which may render it unsafe or harmful for use.

·         Any drug which claim to cure or prevent any disease or ailment described in schedule J.

·         Any drug or cosmetic the import of which is prohibited by rules.

 Import of drug & cosmetics permitted under license only

·         Drugs specified in schedule C & C1

·         Drugs specified in schedule X

·         Drugs for examination, test or analysis.

·         Drugs for personal use

·         Any new drug

Import of schedule C & C1 drugs

·         The license for the import of schedule C & C1 drug is granted subject to the following condition.

·         Licensee must have adequate facilities for the storage of imported drugs so that the properties of drugs are preserved.

·         Licensee must maintain the records of sale of drugs showing particulars of the names of the drugs & of the persons to whom they have been sold.

·         Licensee must allow the inspector to inspect the premises where imported drugs are stored & to check the record & to take the samples for test or analysis.

·         Licensee on request, shall supply the samples of drugs from all batches to the licensing authority for test or analysis.

·         Licensee must not sell the drugs from any batch from which samples have been supplied to the licensing authority, except under the advise of the licensing authority.

·         The licensee must comply with the undertaking given in form 9.

·         The import license may be cancelled or suspended, if conditions are not satisfied.

Import of schedule X drugs

·         The license for the import of schedule X drug is granted subject to the following condition.

·         Licensee must have adequate facilities for the storage of imported drugs, so that the properties of drugs are preserved.

·         Licensing authority may also refuse to grant the license if the license granted to the applicant previously was suspended or cancelled. Or in case if the applicant failed to comply with any provision of the act ie drug & cosmetics act or NDPS

·         However if the applicant is not satisfied with the decision may appeal to central government within 30 days.

Import of small quantities of drug for examination, test or analysis

·         Small quantities of drugs, the import of which is prohibited under the act may be imported for the purpose of examination, test or analysis, subject to the following conditions.

·         The licensee must use imported drug exclusively for the purpose for which they are imported & specified in the license.

·         Licensee must maintain the records of imported drugs, showing particulars of their quantities, names of manufacturer & date of import.

·         Licensee must allow the inspector to inspect the premises where imported drugs are kept & to check the record & to take the samples for test or analysis.

·         Licensee must comply with other conditions as prescribed.

Import of drugs for personal use

·         Small quantities of drugs, the import of which is otherwise prohibited may be imported for personal use without any license subject to the following conditions.

·         The drug shall form the passenger’s bonafide luggage & shall exclusively be for personal use of the passenger.

·         The drug shall be declared to the customs authority, if they direct so.

·         The quantity of any single drug so imported shall not exceed 100 doses.

·         The licensing authority may in an exceptional case, sanction the import of large quantity. Drug is not forming a part of bonafide personal luggage if

·         The drug is for bonafide personal use.

·         The quantity to be imported is reasonable & is covered by prescription of RMP.

Import of new drug

·         No new drugs are allowed to imported without the sanction of the licensing authority.

·         The importer of new drug when applying for permission, shall produce all documentary evidence & other evidences relating to its standards, standards of quality & purity, strength, and such other information including the clinical trials; to the licensing authority.

Import of drug without license or permit

·         Drugs other than those discussed above, may be imported without any permit or license.

·         However before such drugs are imported into the country, the importer should submit a declaration to the custom collector that they comply with all the provisions of chapter III of D&C Act.

Places through which the drugs are imported

·         By Sea: Mumbai, Chennai, Kolkata, Cochin, Vishakhapattanam & Nhava sheva

·         By Air: Delhi, Mumbai, Chennai, Kolkatta, Ahmedabad & Hyderabad

·         By Rail:  Ferozpure cantt & Amritsar Rly station (for drugs coming from pakistan)  Ranaghat, Bongaon & Mahiassan (for drugs coming from Bangladesh) Raxaul (for drugs coming from Nepal)

Drugs exempted from provisions regulating imports of drug

·         Substances not intended for medical use. (condition: label should bear that not for medicinal use.)

·         Following substance which are used both as article of foods & drugs. (Condition: Exempted from all provisions of chapter III)

-        All condensed or powdered milk.

-        Farex, oats, lactose, cerelac except for parenteral use.

-        Virol, Bovril, Chicken essence & other similar predigested food.

-        Cinnamon, pepper, zinger & other condiment & spices.

Import of New Homeopathic Medicine:

‘New Homoeopathic Medicine’ means:

·         A Homoeopathic medicine which is not specified  in  the  Homoeopathic Pharmacopoeia of India or United States of America or of the United Kingdom or the German Homoeopathic Pharmacopoeia; or

·         Which is not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended; or

·         A combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended

·         New Homoeopathic medicine shall not allow to import except under the permission of the Licensing Authority, licensee shall submit the document which explains the therapeutic efficacy 6.

·         No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IX- A 

 

Offences & Penalty related to import of drug

·         Imports adulterated or spurious drug or cosmetic or cosmetic unsafe for use is  Punishable with imprisonment upto 3 years or with fine upto 5,000 or both on first conviction n & punishable with imprisonment upto 5 years or with fine upto 10,000 or both on subsequent conviction

·         Imports any drug or cosmetic the import of which is prohibited under section 10 is Punishable with imprisonment upto six months or with fine upto 500 or both on first conviction n & punishable with imprisonment upto 1 year or with fine upto 1,000 or both on subsequent conviction

·         Imports any drug or cosmetics, the import of which is prohibited in the public interest is Punishable with imprisonment upto 3 years or with fine upto 5,000 or both on first conviction  punishable with imprisonment upto 5 years or with fine upto 10,000 or both on subsequent conviction

 

 

MANUFACTURE OF DRUGS

Manufacture in relation to any drug or cosmetics includes any process or part of process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic for sale or distribution

but does not include compounding or dispensing of any drug or in the ordinary course of retail business

Kinds of manufacturing licenses

·         License for manufacture of schedule C & C1 drugs

·         License for manufacture of schedule X drugs

·         License for manufacture of drugs other than those specified in schedule C & C1, X.

·         License for manufacture of drugs meant for examination, test or analysis.

·         Loan license

For the purpose of this rule a 'loan licence' means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 32.

 

·         Repackaging license

Repacking license are granted for breaking up of any drug other than those specified in Schedule C, & C1, on application to LA in Form 24B & license is issued in Form25B.

Taking into consideration, the proposal on measures need to be taken to address the issue of repacking of Active Pharmaceutical Ingredients into smaller packs by wholesalers for sale, the DCC committee of the CDSCO reiterated that the same cannot be allowed to protect the integrity and quality of the products Active Pharmaceutical Ingredients (Bulk drugs) can be manufactured and sold directly to the formulator or through the wholesaler in accordance with the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under.

·         The repacking operation must be carried out under hygienic conditions & under supervision of competent staff namely

-         A person who holds an approved Diploma in Pharmacy or is an Registered Pharmacist.

-        A person who has passed intermediate examination with Chemistry as principal subject.

-        A person who has passed matriculation & has at least 4 yrs practical experience in manufacturing, dispensing or repacking of drugs.

·         Factory conditions must specify conditions prescribed in Schedule M.

·         Applicant must have in his premises adequate facilities for the testing of drugs.

·         License must be kept at licensed premises & produced on request of DI

 

Manufacture of biological & other special products specified in schedule C&C1

A person licensed to manufacture schedule C & C1 drugs, is required to observe the following conditions (General Condition)

·         Licensed premises must conform to the requirements of GMP specified in schedule M.

·         The licensee must provide adequate arrangement for testing the strength & quality of drugs.

·         The manufacture of drugs must be carried out under active direction & personal supervision of technically qualified staff (who should be either n a) graduate in pharmacy or pharmaceutical chemistry with at least 18 months experience in the manufacture of drugs or n b) a graduate in medicine with at least 3 years experience in the manufacture & testing of drugs or c) Graduate in science with chemistry or microbiology as the principal subject or graduate in chemical engineering with at least 3 years experience in the manufacture & testing of drugs or  d) Any other equivalent foreign qualification.

·         Licensee must have adequate facilities for the storage of imported drugs, so that the properties of drugs are preserved.

·         Licensee must maintain the manufacturing & analytical records of the drugs (records should be preserved for at lest 2 years after the expiry of date for drugs with expiry & 5 years from the date of manufacture for other drugs.

·         Licensee must allow the inspector to inspect the premises where imported drugs are kept & to check the record & to take the samples for test or analysis.

·         Licensee must inform to the licensing authority about any changes in the technical staff or any material changes in the plant or premises since the date of last inspection.

·         Licensee on request, shall supply the samples of drugs from all the batches to the licensing authority for test or analysis.

 

Schedule M

• Good Manufacturing Practices (GMP)

• Guidelines are meant to assure the quality of drugs.

• Draft of GMP was prepared in 1975 & finalized & implemented in 1988

 • Part I deals with Good manufacturing practices relating to factory premises.

• Part II deals with plant & equipment for the manufacture of drugs.

 

 Factory Premises

·         General Requirements of Location of factory & its surroundings

·         Should ensure freedom from contamination due to sewage drain, etc & obnoxious odors or fumes, or large quantity of soot, dust or smoke.

·         Factory building should be constructed to ensure production of drugs under hygienic conditions.

·         Operations such as manufacturing, processing, packing labelling & testing should be carried out in such a way that mix up & cross contamination are prevented.

·         Premises should be constructed and maintained as to prevent entry of insects & rodents,

·         Interior surface should be smooth & free from cracks & permit easy cleaning disinfection.

·         Adequate lighting, ventilation & humidity must be maintained.

·         Drainage systems should be underground, the sanitary fitting & electrical fixtures in the manufacture area must be concealed.

·         Water used must be free of pathogenic micro organisms and of drinkable quality.

·         Waste water should be treated before disposal.

·         There should be a validated system for the treatment of water so as to produce purified water confirming to IP specification.

·         Water should be stored in tanks and freedom from microbial growth must be ensured. The tanks should be cleaned periodically and the records should be maintained.

·         Provisions should be made for the roper storage of the materials awaiting disposal.

·         The disposal of sewage and effluents shall be as required under the Environmental Pollution control board while all biomedical waste must be destroyed as per the rules of Biomedical Waste Management and Handling rules.

 

Warehousing Area

·         Adequate areas shall be designed & provided with proper bins, racks & platforms for the storage and warehousing of all materials & products, machine & equipment's etc.

·         Warehousing area must be clean, dry & maintained within acceptable temperature limits.

·         Storage areas should have appropriate house keeping & rodents, pests & vermin control procedures & records should be maintained.

·         Active raw materials and excipients must require separate sampling and warehousing area.

·         Regular checks should be made to ensure adequate steps taken against spillage, breakage and leakage of containers.

Production Area

·         The equipment's and materials must be placed orderly & the movement of personnel must be restricted to avoid cross contamination.

·         Separate dedicated self containing facilities should be made available for the production of sensitive pharmaceutical products like penicillin or biological preparations with live microorganisms.

Laboratories

·         shall be designed to avoid mix-ups and cross- contamination. Separate instrument room with adequate area shall be provided for sensitive & sophiscated instruments employed for analysis.

·         Suitable storage space shall be provided for test samples, retained samples, reference standards, reagents & records.

·         Personnel o Manufacture/testing shall be conducted under the direct supervision of competent technical staff & head of quality control laboratory shall be independent of manufacturing unit.

·         Personnel in quality control and quality control operations shall be suitably qualified & experienced & appropriate training must be given to them in the duties & responsibilities assigned to them.

Health, Clothing & Sanitation of workers

·         All personnel coming to contact with products & raw materials should be free from contagious diseases & should undergo periodic health check up. Just before entry to manufacturing area, room with facility for personnel cleanliness should be provided.

·         Prior to employment, personnel shall undergo medical examination & shall be free from TB, skin and other communicable/contagious diseases.

·         Periodical medical examination at least once an year may be necessary.

·         All persons prior to & during the employment shall be trained in practices that ensure personnel hygiene.

 

·         Direct contact shall be avoided b/w unprotected hands of personnel raw materials, intermediate, or finished unpacked products.

·         All persons should wear clean body coverings.

·         Smoking, eating, drinking, chewing or keeping plants or food & personnel medicines shall not be permitted in production, laboratory storage & other areas.

·         Rest & refreshment rooms should be separate & should not lead directly to the manufacturing area.

·          Facilities for changing, storing of clothes & for washing & toilet purposes should be provided and must be adequate for the number of users.

Sanitation in Manufacturing premises:

·         Manufacturing area should not be utilized for any other purposes & should be maintained clear & in orderly manner free from accumulated waste, dust, debris etc.

·         A routine sanitation program must be exercised.

·         Production areas shall be well lit, particularly where visual online controls are carried out.

Raw Materials:

·         All raw materials must be  Purchased from approved sources under valid purchase vouchers, possibly from producers directly.

·         Identified & their containers examined for damage& assigned control number.

·         Identified & their containers examined for damage& assigned control number.

·         There shall be separate areas for materials under test, approved & rejected.

·         Materials must be stored in such a way that first in/first expiry, first out principle can be applied.

·         Only raw materials released by QC department & which are within their shelf life shall be used.

Sterile Products

·         Design of area must avoid possibility of mix up between sterile & non sterile products.

·         Access to manufacturing area must be restricted to authorized personnel only.

 

 

 

 

 

 

Special provision related to biological or other special product must comply.

·         All schedule C drugs must be issued in a previously sterilized glass containers sealed so as to prevent entry of bacteria.

·         Drugs must comply with the standards of strength, quality & purity as specified in schedule F.

·         Biological products such as sera, vaccine, antigen, antitoxin, insulin etc. should be tested for the absence of living & anaerobic microorganism.

·         The test for sterility must be carried out.

Manufacture of drugs specified in schedule X

In addition to general conditions as mentioned before the licensee should observe the following conditions.

·         Accounts of all transactions relating to the manufacture should be maintained in a serially bound & paged register.

·         Drugs should be stored in bulk & they should be kept in a separate place in the custody of responsible person.

·         Licensee must submit a report to the licensing authority every 3 months regarding manufacture & sale of drugs.

·         No schedule X drugs should be supplied by way of physician sample.

  

Manufacture of drugs other than those specified in schedule C,C1 & X

 In addition to general conditions as mentioned before the licensee should observe the following conditions.

·         The licensee should maintain an inspection book in which the inspector may record their inferences.

·         If the licensee desires to undertake the manufacture of any additional categories of drugs he should pay a fee of Rs. 10 for each such additional category.

·         Licensee must comply with such additional requirements of which he has been given at least 4 months notice by the licensing authority.

Manufacture of drugs for examination, test or analysis

 The following conditions must be observed by the licensee.

·         Licensee must use manufactured drug exclusively for the purpose for which they are manufactured.

·         Licensee must maintain the records of the manufactured drugs, showing particular of their quantities & names of the persons to whom they have been supplied.

·         Licensee must allow the inspector to inspect the premises where drugs are kept & to check the record & to take the samples for test or analysis.

·         Licensee must comply with such additional requirements of which he has been given at least 1 month notice by the licensing authority.

 

 

 

 

 

 

 

 

 

Loan License

It means a license issued by the licensing authority to a applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by another licensee.

Application for grant of loan license

·         should be supported by documentary consent of the licensee whose facilities he is going to use.

·         Before granting a license the authority may satisfy himself that the person, whose facilities applicant wishes to use must possess necessary staff, equipment & space for manufacture of drugs.

·         The loan license shall be deemed to be cancelled or suspended, if the license owned by licensee whose manufacturing facilities have been availed by the licensee is cancelled or suspended.

·         The licensee must test each batch of raw material & finished product.

·         Licensee should maintain manufacturing & analytical records of drugs.

·         Licensee must allow the inspector to inspect the premises where drugs are kept & to check the record & to take the samples for test or analysis.

Repacking License

It means the process of breaking up any drug from a bulk container into small packages & the labeling of such package with a view to its sale & distribution,

Person licensed to repack drug should observe the following condition.

·         Licensed premises must conform to the requirements of GMP specified in schedule M.

·         Licensee must provide adequate arrangements for testing the strength & quality of drugs.

·         The manufacture of drugs must be carried out under active direction & personal supervision of competent person.

o   person who either holds diploma in pharmacy or Registered pharmacist under pharmacy act.OR

o   Have passed the intermediate examination with chemistry as principal subject.OR

o   Have passed matriculation examination & have not less than 4 years of experience in manufacturing or dispensing or repacking of drugs.

·         Licensee must have adequate facilities for the storage of drugs, so that the properties of drugs are preserved.

·         Licensee must maintain the records for the repacking of drugs. n

·         Licensee must allow the inspector to inspect the premises where drugs are repacked & to check the records & to take the samples for test or analysis.

·         Licensee must inform to the licensing authority about any changes in the technical staff or any material changes in the plant or premises since the date of last inspection.

·         Licensee on request, shall supply the samples of drugs from all the batches to the licensing authority for test or analysis.

·         In addition to other particulars, the repacked drug should bear the no. of license with words “Rpg. Lic. No.” on its label.

·         The license should be kept on the licensed premises & should produce before an inspector on demand.

·         Licensee should comply with the provisions of the act.

 

0fenses & Penalties for manufacture of drugs

·         Manufacture of drug/ adulterated drug/ spurious drug likely to cause death or grievous body hurt as per sec. 320 of IPC. ¨ 5 years----life imprisonment & not less than Rs. 10,000 fine.

·         Manufacture drugs without license or adulterated drug not likely to cause death or grievous body hurt ¨ 1-3 years imprisonment & not less than Rs. 5,000 fine.

·         Manufacture of drug in contravention of any other provision. ¨ 1-2 years imprisonment & with fine.

·         Failure to keep records or disclose required information 1 year imprisonment & or fine Rs. 1,000

·         Use of Govt. analyst report for advertising

·          Fine upto Rs.500