Administration of the Drugs and Cosmetics Act 1940 and Rules 1945 – Drugs Technical Advisory Board (DTAB), Central Drugs Laboratory, Drugs Consultative Committee, Government analysts, licensing authorities, controlling authorities, Drug Inspectors.

Administration of the Act and Rules – Drugs Technical Advisory Board, Central Drugs Laboratory, Drugs Consultative Committee, Government analysts, licensing authorities, controlling authorities, and Drug Inspectors.

The Drugs Technical Advisory Board (DTAB).

The Central Government constitutes a Board called the Drugs Technical Advisory Board (DTAB).

Functions:

DTAB is purely advisory in function. DTAB performs the following functions

• 1. To advise the Central Government and the State Governments on technical matters related to the administration of the Drug and Cosmetic Act.

• 2. Functions assigned to DTAB by the central government.

• 3. The central government makes rules related to the import, manufacture, or distribution of drugs and cosmetics after consulting DTAB and on the recommendation of DTAB. The central government makes rules related to drugs and cosmetics on the recommendation of DTAB.

• 4. The Central Government may make rules related to drugs and cosmetics without consulting DTAB. However, the central government has to consult DTAB within 6 months. The central government considers the suggestion of DTAB.

• DTAB consists of ex-officio, elected, and nominated members. The Board shall consist of the following members:

Ex Officio Members

• (i) The Director General of Health Services, who shall be Chairman

• (ii) The Drugs Controller of India,

• (iii) The Director of the Central Drugs Laboratory, Calcutta

• (iv) The Director of the Central Research Institute, Kasauli

• (v) The Director of Indian Veterinary Research Institute, Izatnagar,

• (vi) The President of the Medical Council of India

• (vii) The President of the Pharmacy Council of India,

• (viii) The Director of Central Drug Research Institute, Lucknow,

Nominated Members

• (ix) Two persons are nominated by the Central Government from among persons who are in charge of drug control in the States( State Drug Controller)

• (x) One person is nominated by the Central Government from the pharmaceutical industry

• (xi) Two government Analysts appointed under the Drug and Cosmetic Act are nominated by the central government.

Elected Members

• (xii) One person, is elected by the Executive Committee of the Pharmacy Council of India, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy of an Indian University or a college affiliated with the university

• (xiii) One person, is elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics of an Indian University or a college affiliated with an Indian university;

• (xiv) one pharmacologist is elected by the Governing Body of the Indian Council of Medical Research (ICMR);

• (xv) one person is elected by the Central Council of the Indian Medical Association (IMA);

• (xvi) One person is elected by the Council of the Indian Pharmaceutical Association

• The nominated and elected members of the Board shall hold office for three years. If their membership in their original position is ceased then automatically their membership of DTAB shall also be ceased. For example person is elected to be a teacher in a university. If he is no more teaching staff of the university or college, his DTAB membership will also be canceled. Similarly, a state drug controller is nominated by the central government. If he no longer remains the state drug controller for any reason then his membership in DTAB shall be ceased. The same rule shall apply to all nominated and elected members. They are eligible for re-nomination and re-election. DTAB is reconstituted after 3 years. The Board may make by-laws fixing a quorum and regulating its procedure and conduct after due permission from the central government.

• The Board may constitute sub-committees for specified periods for any specified purpose. The duration of the subcommittee's existence should not exceed three years. DTAB can include persons in the subcommittee who are not members of the DTAB.

• The Central Government shall appoint a person to be Secretary of the Board. Central government shall also provide clerical and other staff to perform various activities in DTAB

Alok Bains

The Central Drugs Laboratory

The Central Government established a Central Drugs Laboratory at Kolkata. The director of the central drug laboratory is appointed by the central government. Central Drug Laboratory carries out the functions assigned to it by the Drug and Cosmetic Act or any rules made under this act. The central government also assigned other duties to the central drug laboratory after consulting DTAB.

The following are the main functions of the central drug laboratory

• 1. Analysis or testing of samples of drugs and cosmetics forwarded to it by the courts or the customs collectors

• 2. To carry out duties assigned by the central government or by the state government after consultation with DTAB.

The power of the director of the central drug laboratory, Kolkata will be exercised by the following regarding special categories of drugs:

• 1. Power of the central drug laboratory regarding biological and microbiological products such as sera, vaccines, toxins, antigens, sutures, bacteriophages, serum protein solution for injection, etc are carried out at central research institute Kasauli Himachal Pradesh. The director of this institute exercises the power of the director, of the central drug laboratory in Kolkata.

• 2. Analysis and testing of above said products meant for animal uses are carried out at the Indian Veterinary Institute Izatnagar, Uttar Pradesh. The Director of the Institute shall exercise the Power of the director, of the central drug laboratory Kolkata.

• 3. Indian Pharmacopoeia Laboratory Ghaziabad, Uttar Pradesh shall perform analysis and testing of condoms. The director of Indian Pharmacopoeia Laboratory, Ghaziabad shall exercise the power of the director, of Central Drug Laboratory, Kolkata to test and analyze condoms.

• 4. Testing and analysis of oral polio vaccines shall be carried out at the National Institute of Communicable Diseases, Delhi. Dy. director of this institute shall exercise the power of the director, of central drug laboratory Kolkata to analyze and test oral polio vaccine.

• 5. Testing and analysis of VDRL antigen shall be carried out by serologists and chemical examiners to the Government of India. He will exercise the power of the director, of the central drug laboratory, Kolkata.

Courts send all samples of drugs and cosmetics to the director, central drug laboratory, Kolkata under registered post in a sealed cover along with a memorandum. A specimen impression of the seal used on the sample container and a copy of the memorandum are also sent to the director, central drug laboratory separately through registered post. The director or any authorized officer shall record the condition of the seal after receiving the sample packet. They shall compare the seal condition of both seal impressions received separately before starting the analysis and testing of samples. All other directors of the different laboratories mentioned above will follow the same procedure to analyze or test received samples.

The director shall supply a report of analysis and testing with the full protocol of testing. The report should be duly signed by the director or any other officer deputed for this purpose by the central government through notification in the official gazette.

The Drugs Consultative Committee.

The central government constitutes a drug consultative committee to advise the Central Government, the State Governments, and the Drugs Technical Advisory Board. drug consultative committee advises them to secure uniform implementation of the Drug and Cosmetic Act administration throughout India.

The Drugs Consultative Committee consists of two representatives of the Central Government nominated by the central government and one representative of each State Government to be nominated by the State Government concerned. The Drugs Consultative Committee shall hold meetings whenever required to do so by the Central Government. It has the power to regulate its procedure.

Alok Bains

Drugs Control Laboratories in states

Each state in India establishes a drugs control laboratory to analyze or test samples of drugs and cosmetics manufactured and sold within their respective territory. Drug inspectors take samples of drugs from premises licensed to manufacture or sale of drugs while inspecting these premises. Drug inspectors send these samples to drug control laboratories in their respective states. Government analyst appointed by the state government under the Drugs and Cosmetics Act and analyzed samples received in the laboratory. Private persons or any other concerned persons can also send samples for analysis and receive reports on the payment of prescribed fees.

Government Analyst

Each state government appoints one or more government analysts to test and analyze samples of drugs and cosmetics in the state drugs control laboratory under Chapter IV and Section 20 of the Drugs and Cosmetics Act 1940. A government analyst is appointed for a specified area or a specified category of drugs. A government analyst is appointed by each state government as per provisions of the Drugs and Cosmetics Act for the whole state or the specified area in the state. The central government may also appoint a government analyst if there is any need for such an appointment for a specified category of drugs. Persons already working in the central government or state government can also be deputed as government analysts after due permission from the concerned government. Persons appointed or deputed as government analysts should not have any financial interest in the import, manufacturing, and sale of drugs and cosmetics.

Qualifications to be a Government Analyst

• 1. Graduate in pharmacy, pharmaceutical chemistry, science, or medicine with five years experience of in testing and analysis of drug samples under the control of

  • a. Government Analyst appointed under the Drugs and Cosmetics Act 1940  OR

  • b. Head of the institution or testing laboratory duly approved by the state drug administration department to test and analyze samples of drugs and cosmetics

• 2. Postgraduate in pharmacy, pharmaceutical chemistry, science, or medicine with three years experience of in testing and analysis of drug samples under the control of

  • a. Government Analyst appointed under the Drugs and Cosmetics Act 1940    OR

  • b. Head of the institution or testing laboratory duly approved by the state drug administration department to test and analyze samples of drugs and cosmetics

• 3. Associateship diploma from the institution of chemist (India) obtained after passing the examination with subject analysis of drugs and pharmaceuticals as one of the subjects and have three years experience in testing and analysis of drugs and cosmetics under the control of

  • a. Government Analyst appointed under the Drugs and Cosmetics Act 1940 OR

  • b. Head of the institution or testing laboratory duly approved by the state drug administration department to test and analyze samples of drugs and cosmetics

• Government analysts appointed to analyze schedule C drugs (biological drugs) should have three years of experience in testing these schedule C drugs in approved laboratories. He should have evidence of training in physiology, bacteriology, serology, pathology, pharmacology, or microbiology.

• Government analysts appointed to test and analyze veterinary biological products should be graduates in pharmacy, veterinary science, general science, or medicine with 5 years of experience in manufacturing, storage, distribution, testing, and analysis of veterinary biological products.

• Government analysts appointed to test and analyze veterinary biological products should be postgraduate in pharmacy, veterinary science, general science, or medicine with 3 years of experience in manufacturing, storage, distribution, testing, and analysis of veterinary biological products.

Duties of Government Analyst

• 1. To analyze and test samples of drugs and cosmetics forwarded by drug inspectors

• 2. To analyze and test samples of drugs and cosmetics sent with a prescribed fee by any other person.

• 3. To furnish a report of the sample received along with a protocol for testing and analyzing of received samples

• 4. To engage in any research work and to forward it to the state government from time to time.

• 5. To publish analytical and research work with due permission from the government.

Procedure

• Drug Inspectors send samples in sealed containers for testing and analysis. Government analyst records the condition of the seals on the sample package after receiving of sample. The drug inspector also sends the impression of the seal on the sample package separately. Government analysts compare the seal on the package and the impression of the seal received separately. The government analyst performs testing and analysis of the sample. Prepare a report of analysis and testing in triplicate. Government analyst supplies triplicate copies of testing and analysis of samples. Government analysts also supply written detailed procedures followed to test and analyze given samples.

• A report duly signed by a government analyst is considered evidence in court. Anyone can challenge a report supplied by a government analyst within 28 days from the date of the analysis report. In this condition, the sample is sent to the central drug laboratory in Kolkata for analysis and testing. Report supplied by the central drug laboratory shall be considered as final.

Drug Inspector

The central government and state government appoint a suitable number of drug inspectors under Chapter IV and Section 21 of the Drugs and Cosmetics Act 1940 for specified areas. Drug inspectors perform their duties in specified areas. Drug inspectors appointed as per provisions of the Drugs and Cosmetics Act should not have any financial interest in the import, manufacture, and sale of drugs and cosmetics. All drug inspectors are considered public servants under section 21 of the Indian penal code. Drug inspectors must keep all information confidential while performing duties. The information would be disclosed only on demand of a court of law.

Usually, inspectors are appointed for the following two purposes

• 1. To inspect premises licensed to manufacture drugs

• 2. To inspect premises licensed to sale of drugs

Qualifications

• 1. Degree in pharmacy or pharmaceutical chemistry or postgraduate in science with pharmaceutics as a special subject from a recognized university or

• 2. Associateship diploma of the institution of the institution of chemist (India) awarded after passing examination with analysis of drugs and pharmaceuticals as one the subjects Or

• 3. “Pharmaceutical Chemist Diploma” of the Pharmaceutical Society of Great Britain Or

• 4. Degree in Medicine or Science with at least one year’s post-graduate training in a laboratory under control of:

  • a. A Government Analyst appointed under the Drugs and Cosmetics Act

  • b. A Chemical Examiner

  • c. A Fellow of the Royal Institute of Chemistry of the Great Britain (Branch E)

  • d. The head of the Institution approved by the appointing Authority

Appointing authority can appoint an ex-officio inspector to inspect shops in any area from the medical or public health department. This inspector should have a degree in medicine or science or a registered medical practitioner.

To inspect licensed premises to manufacture schedule-C drugs, a drug inspector should have 3 years of experience in manufacturing or testing schedule-C drugs in a laboratory approved for this purpose by the licensing authority.

To inspect licensed premises to manufacture veterinary biological products, a drug inspector should have a degree in pharmacy or medicine or veterinary science or science with three years of experience in manufacturing and testing such products.

Power and Duties of Drug Inspectors

Under Chapter IV and Section 21 subsection 2 drug inspectors exercise their power and perform their duties as prescribed by the appointing authority.

The duties to be performed by drug inspectors are

• 1. To Inspect premises licensed to sale of drugs

• 2. To Inspect premises licensed to manufacture of drugs and cosmetics

Appointing authority can assign both duties or any one of the duties specified above to drug inspectors. Appointing authority also notifies specified areas to drug inspectors to perform their duties.

Power of Drug Inspectors

Section 23 under Chapter IV of the Drugs and Cosmetics Act 1940 provides the following power for drug inspectors to exercise while performing their duties

A. Inspection of premises licensed to sale of drugs

Drug inspectors exercise the following power while performing their duty to inspect premises licensed for the sale of Drugs’

• 1. Drug inspectors inspect all premises licensed for sale in his area at least twice in a year. They will satisfy themselves that provisions of drug and cosmetics rules have been followed by the licensee.

• 2. Drug inspectors take samples of drugs while inspecting premises and send them to government analysts for analysis. Drug inspectors can take samples from the licensee himself (dealer) or persons conveying, delivering, or preparing to deliver drugs to the purchaser

• 3. Drug inspectors investigate any complaints made in writing to him. They will enquire all matters to investigate unlawful activities i.e. against the Drugs and Cosmetics Act and rules in licensed premises.

• 4. Drug inspectors can enter and search all places, vessels, vehicles, or persons if he has sufficient reasons that an offense under the act has been committed. He exercises this power at a reasonable time. He may take the assistance of authorized persons to exercise this power. He can pass orders to the person possessing such contraband drugs not to dispose of such drugs for a specified period. The duration of this period should not be more than 20 days. They can seize stock of drugs if the defect is of a nature that cannot be corrected.

• 5. Drug inspectors lodge legal proceedings if there is any activity against the Drugs and Cosmetics Act and Rules.

• 6. Drug inspectors can detain imported drugs that have been prohibited to be imported. But they will exercise this power only after due permission from the state government.

• 7. Drug inspectors can exercise any other powers to enforce the implementation of provisions of the Drugs and Cosmetics Act and Rules.

• 8. Drug inspectors shall maintain records of all inspections and actions taken by them, samples taken from licensed premises, and seizure of stocks. They will submit records of these to the licensing authority or controlling authority.

B. Inspection of premises licensed to manufacture drugs and cosmetics

Drug inspectors exercise the following powers while performing a duty to inspect premises licensed to manufacture Drugs and Cosmetics. Drug inspectors exercise these powers only after due instructions to do so from the controlling authority

• 1. Drug Inspectors inspect licensed premises to manufacture drugs at least two times a year. They will inspect the method of drug or cosmetic manufacturing, place of storage, technical qualification of staff, location of establishment, etc. They will satisfy themselves that provisions of the Drug and Cosmetics Act have been followed

• 2. Drug inspectors take samples of drugs manufactured in licensed premises. They send samples to government analysts for testing and analysis

• 3. Drug Inspectors check all records and registers maintained under rules. They will satisfy themselves that all records have been maintained as per provisions of the Drugs and Cosmetics Act and Rules.

• 4. Drug Inspectors send each inspection report to the controlling authority.

Procedures of Inspectors

Section 23 under Chapter IV of the Drugs and Cosmetics Act laid down procedures to be followed by drug inspectors while exercising their powers to perform their duties.

1. Taking Sample of Drugs: Drug inspectors take samples after informing the licensee in writing. They will also pay the price of the sample to the licensee and take receipt of payment. If the licensee cannot accept the price of the sample then the drug inspector issues a receipt stating the details of the sample and the quantity of the drug taken in a prescribed format. He will take the signature of the licensee on a duplicate copy of the receipt given to the licensee.

The drug inspector divides samples into four parts in the presence of the licensee or any authorized person from the licensee. The drug inspector will seal each sample, put his suitable mark, and also allow the licensee or authorized person from the licensee to put his mark on sealed samples.

If the sample is taken from premises licensed to the sale of drugs then one sample will be sent to a government analyst, one for a drug inspector to be produced in court if there is any legal proceeding, one sample will be sent to the manufacturer and one sample will be returned to the licensee or any authorized person from licensee. The sample is sent to a government analyst by registered post or the sample is delivered personally in a sealed container. Drug inspector decides further line of action after receiving a report from a government analyst.

If the sample is taken from premises licensed to manufacture drugs then the sample is divided into three parts. One is for a government analyst, one is for a drug inspector himself and one is for the licensed manufacturer. The same procedure is followed as stated above. If the size of the sample container is very small and cannot be divided into four or three parts. Then four or three containers are taken by drug inspectors. The procedure stated above is followed for samples taken.

2. Entry and Search of premises, vehicle, etc: A drug inspector can enter any place if he has sufficient reason or information that the drug has been stocked illegally in that place. He can enter such places or vehicles alone or with assistance at any reasonable time. to search for them. He can check any vessels or any person if he has sufficient reason or information regarding contravention of the Drug and Cosmetic Act and rules. He can stop and search any vehicle if he has sufficient reason to do so. Any wilful obstruction will be considered as a disturbing government officer to perform his duty. That obstruction can be removed by a drug inspector or a drug inspector can use any assistance to remove such obstruction.

The drug inspector will ascertain to perform his duty speedily. If there is any contravention of the act then the drug inspector will size that stock and stop the person not to selling such drugs. If the drug inspector thinks that there is no contravention of a provision of the act then he will revoke his order not to sell. He will also return the seized drug to the concerned person. During search and examination, the drug inspector will also examine all records, registers, documents, materials, and objects. He can also cease them if there is any reason to do so.

3. Seizure of Stock: Drug inspectors seize records, registers, documents, materials, and objects as evidence if there is any contravention of the act or any offense committed under the Drugs and Cosmetics Act. Drug inspector informs city magistrate regarding seizure of records, registers, documents, materials, and objects as soon as possible. He will take a custody order from the magistrate to keep all these seized materials under his custody. Seized records, registers, documents, materials, and objects should be returned within 20 days after making extracts or copying all documents.

Alok Bains