Administration of the D & C Act, 1940

Various administrative bodies in details of the Drugs & Cosmetics Act, 1940.

1. ADMINISTRATION OF THE DRUGS & COSMETICS ACT, 1940 1

2. Mr. Shaktiprasad Pradhan M.Pharm, Ph.D* Research Professional, UDPS [email protected] Utkal University, Bhubaneswar Odisha, India 2

3. . INTRODUCTION 3

4. THE DRUGS & COSMETICS ACT, 1940 The modern medicines have been imported by India till after the first word war which made India mostly dependent. In August 1930 , the Government of India, under the Chairmanship of R.N. Chopra appointed a Drug Enquiry Committee for the quality & standard of drugs sold and recommendation for control measure. In 1937 , a bill was introduced to give effect to the recommendations of the Drugs Enquiry Committee in the Central Legislative Assembly for a more comprehensive measure for the uniform control of import, manufacture, distribution and sale of drugs was desirable. In 1939 , the Drug Import Bill was prepared & placed for consideration before the Central Legislative Assembly. In 10th April, 1940 the bill was passed & received assent of the Governor General in Council & became the Drugs and Cosmetics Act, 1940 . In 1945 , the related Drugs Rules of the D & C Act, 1940 were passed. 4

5. . OBJECTIVES & ROLE OF THE D & C ACT, 1940 5

6. Objectives of the D & C Act, 1940 The Act visualizes the regulatory control over the drugs imported in to the country by the Central Government while the manufacture , sale and distribution of drugs is primarily regulated by the State Drug Control Authorities appointed by the respective State Governments . The primary objective of the Act is to ensure that the drugs & cosmetics sold in India are safe , effective and conform to state quality standards and to make available Standard Quality drug/ cosmetic to consumer . The manufacture and sale of the drugs is regulated through a system of licensing and inspection by the Licensing Authorities . (Cont.) 6

7. The Central Drugs Standard Control Organization (CDSCO) , headed by the Drugs Controller General, India (DCGI) is concerned with the regulatory control over the quality of drugs & cosmetics . Role of the D & C Act, 1940 To prevent substandard in drugs & maintaining high standards of medical care . To regulate the import , manufacture , distribution and sale of drugs & cosmetics through licensing . To regulate the manufacture and sale of Ayurvedic , Siddha and Unani drugs . To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs & cosmetics. 7

8. . AMENDMENTS IN THE D & C ACT, 1940 8

9. Amendments in the Act and adaptation of Orders 1. The Repealing and Amending Act, 1949 (40 of 1949) 2. The Adoption of Laws Order, 1950 3. The part B States (Laws) Act, 1951 (3 of 1951) 4. The Drugs (Amendment) Act, 1955 (11 of 1955) 5. The Drugs (Amendment) Act, 1960 (35 of 1960) 6. The Drugs (Amendment) Act, 1962 (21 of 1962) 7. The Drugs and Cosmetics (Amendment) Act, 1964 8. The Drugs and Cosmetics (Amendment) Act, 1972 9. The Drugs and Cosmetics (Amendment) Act, 1982 10. The Drugs and Cosmetics (Amendment) Act, 1986 11. The Drugs and Cosmetics (Amendment) Act, 1995 12. The Drugs and Cosmetics (Amendment) Act, 2003 13. The Drugs and Cosmetics (Amendment) Act, 2008 14. The Drugs and Cosmetics (Amendment) Act, 2013 15. The Drugs and Cosmetics (Amendment) Act, 2015 16. The Drugs and Cosmetics (Amendment) Act, 2016   9

10. . CHAPTERS IN THE D & C ACT, 1940 10

11. Chapters in the D & C Act, 1940 Chapter I - Introduction. Short title, extent and commencement and definitions. Chapter II- Various Administrative Agencies. The Drugs Technical Advisory Board, the Central Drugs Laboratory and the Drugs Consultative Committee and its constitution. Chapter III- Import of Drugs and Cosmetics. Standards of quality, Misbranded drugs, Adulterated drugs, Spurious drugs & Cosmetics and prohibition of import of certain drugs or cosmetics. (Cont.) 11

12. Chapter IV- Manufacture, Sale and Distribution of Drugs & Cosmetics. Standards of quality, Misbranded drugs, Adulterated drugs, Spurious drugs & Cosmetics and prohibition of manufacture, sale and distribution of certain drugs or cosmetics. Chapter IV(A)- Provisions relating to Ayurvedic, Siddha & Unani drugs. Chapter V- Miscellaneous. Power to give directions, offences by companies, Government departments, penalties and sentences passed under this Act, Magistrate’s power to impose enhanced penalties, etc. 12

13. . ADMINISTRATION OF THE D & C ACT, 1940 13

14. Administration of the D & C Act, 1940 The D & C Act, 1940 provides for the establishment of various administrative bodies for the smooth administration of the Act through out the country. Advisory Drugs Technical Advisory Board (DTAB) Drugs Consultative Committee (DCC) Analytical Central Drugs Laboratory State Drugs Control Laboratories Government Analysts Executive Licensing & Controlling Authorities Drug Inspectors Customs Collectors (Cont.) 14

15. Drugs Technical Advisory Board (DTAB) DTAB is the highest statutory decision making body on technical matters related to drugs in India. It is a part of the Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health & Family Welfare , Govt. of India. DTAB is constituted under Section-5 of the D & C Act, 1940 by the Central Government to advise both the Central as well the State Governments on technical matters arising out of the administrations. It consists of total 18 members of whom, 8 are ex-officio , 5 nominated and 5 elected members. Both the nominated and elected members hold the office for three years but are eligible for re-nomination and re-election. The Central Government appoints the Secretary and provides the clerical & other staff to the board. (Cont.) 15

16. The board may appoint sub-committees and may appoint persons who are not board members either temporarily or for some period not exceeding 3 years . Ex-officio Members (8 No.) Director General of Health Services, India (DGHS) [CHAIRMAN] Drugs Controller of India (DCGI) [MEMBER SECRETARY] Director, Central Drugs Laboratory, Kolkata (CDL) Director, Central Research Institute, Kasauli (CRI) Director, Indian Veterinary Research Institute, Izatnagar (IVRI) Director, Central Drug Research Institute, Lucknow (CDRI) President, Pharmacy Council of India (PCI) President, Medical Council of India (MCI) (Cont.) 16

17. Nominated Members (5 No.) One person nominated from Pharmaceutical Industry by the Central Government. Two persons from amongst persons who are in charge of drugs control in states nominated by the Central Government. Two Government Analysts , nominated by the Central Government. Elected Members (5 No.) A teacher in Pharmacy or Pharmaceutical Chemistry or Pharmacognosy on the staff of an Indian University or affiliated College, elected by the Executive Committee of Pharmacy Council of India (PCI) . A teacher in Medicine or Therapeutics, on the staff of an Indian University or affiliated College, elected by the Executive Committee of Medical Council of India (MCI) . 17

18. 3. One person , elected by the Council of Indian Pharmaceutical Association (IPA) . 4. One person , elected by the Council of Indian Medical Association (IMA) . 5. One Pharmacologist , elected by the Governing body of the Indian Council of Medical Research (ICMR) . Drugs Consultative Committee (DCC) The Central Govt. may constitute an advisory committee to be called the Drugs Consultative Committee (DCC) to advise the Central Govt. , the State Govt. & the DTAB on any matter tending to secure uniformity throughout the country in the administration of the D & C Act, 1940. The DCC shall consist of 2 nominated representatives of the Central Govt. & 1 nominated representative of each State Govt. . The DCC shall meet when required to do so by the Central Govt. & shall have power to regulate its own procedure. 18

19. Central Drugs Laboratory (CDL) The Central Drugs Laboratory is the national statutory laboratory of the Indian Central Govt. for quality control of Drugs & Cosmetics . It is the oldest quality control laboratory of the Drug Control Administration in India, established in Kolkata under the D & C Act, 1940. It functions under the administrative control of the Director General of Health Services (DGHS) , Ministry of H & FW, Govt. of India. The Central Drugs Laboratory is entrusted with the following functions:  To analyze or test samples of drugs or cosmetics sent to it under sub-section (2) of section 11 , or under sub-section (4) of section 25 of the Act, by the Customs Collectors or Courts. To carry out such other duties as may be entrusted to it by the Central Govt. or by the State Govts. with the permission of the Central Govt. and in consultation with DTAB . (Cont.)   19

20. Biological & microbiological tests or analysis are not carried out in the Central Drugs Laboratory at Kolkata . Hence the samples are required to be sent to the Directors of different research institutes & laboratories who exercise all the functions of the Director , Central Drugs Laboratory , in respect of such classes of drugs. Tests or analysis of the samples of sera, vaccines, toxins, antigens, antitoxins, sterilized surgical ligatures & sutures, bacteriophages, solutions of serum proteins for injection etc. are carried out at the Central Research Institute, Kasauli. Tests or analysis of the samples of antisera, vaccines, toxoids & diagnostic antigens all for veterinary use are carried out at the Veterinary Research Institute, Izatnagar or Mukteshwar . Tests or analysis on the samples of condoms are carried out at the Central Pharmacopoeial Laboratory, Ghaziabad . (Cont.) 20

21. Tests or analysis on the samples of Intra-uterine devices & Falope rings are carried out at the Central Drug Testing Laboratory, Thane . Tests or analysis on the samples of VDRL antigens are carried out at the Laboratory of the Serologist & Chemical Examiner to the Govt. of India, Kolkata . Tests or analysis on the samples of Oral Polio Vaccines are carried out at the Pasteur Institute of India, Coonoor & Enterovirus Research Centre, Mumbai . Tests or analysis on the samples of various diagnostic kits (HIV kit, Hepatitis-B & C kit, Glucose test strips, Biochemical kits, Fibrin Sealant kit etc.) are carried at the National Institute of Biologicals, Noida . Tests or analysis on the samples of all homeopathic medicines are carried out at the Homeopathic Pharmacopoeial Laboratory, Ghaziabad . (Cont.) 21

22. Tests or analysis on the samples of human blood & its products including components, to test for freedom of HIV antibodies, are carried out at National Institute for Communicable Disease, Dept. of Microbiology, New Delhi. National Institute of Virology, Pune. Centre of Advance Research in Virology, Christian Medical College, Vellore. State Drugs Control Laboratories (SDCL) As per the D & C Act, 1940 each of the states of India is required to establish a laboratory for the analysis & testing of drugs and cosmetics manufactured or sold within the State concerned. Samples taken by the Drug Inspectors during the course of inspection of the licensed manufacturing houses & retail establishments are required to be analysed in these laboratories for ascertaining whether they come up to the prescribed standards or not . (Cont.) 22

23. Qualifications of Govt. Analysts A graduate in Medicine/Science/Pharmacy/Pharmaceutical Chemistry of recognized University and have at least 5 years of experience or a postgraduate in the above areas with at least 3 years of experience in testing of drugs in a laboratory under the control of A Government Analyst, or Head of an approved institution or testing laboratory. Duties of Govt. Analysts Analyze and test samples of drugs or cosmetics sent to him by the Drug Inspectors or other persons under the Act and to furnish reports of the results of test or analysis. Engage in any possible research work & forward to their respective Government from time to time, results of analytical & research work with a view to publication at the discretion of the Government. 23

24. Procedure of Govt. Analysts On receipt of package of sample from an Inspector the Government Analyst should compare the seals on the package with the specimen seals and note its condition. On completion of test or analysis, the report in triplicate together with full protocols of the tests or analysis should be sent to the Investigator . Government Analyst has to submit a report in form-1 and unless full protocols are supplied, the report cannot be regarded as conclusive evidence. Reports signed by Govt. Analysts are taken to be evidences of the facts stated theirin unless they are challenged within 28 days . In case of a challenge , the samples may be sent for test or analysis to the Central Drugs Laboratory whose report shall be deemed to be exclusive . 24

25. Licensing & Controlling Authorities (LA & CA) Authorities are appointed by the Central Govt. to issue licences for the import of drugs . The State Governments appoint Licensing Authorities & Controlling Authorities for their respective States to issue licences for the manufacture & sale of drugs and for manufacture of cosmetics . The requisite qualification for the Licensing Authority & Controlling Authority is indicated under 49A & 50A respectively through the 9 th amendment to the D & C Rules, in 1989 . The Licensing Authorities are empowered to issue or refuse to issue licences to prospective applicants, also to cancel or suspend the licences issued by them if there is any kind of contravention of the Act or Rules their under. However their decision can be challenged in the courts of law. (Cont.) 25

26. The Licensing & Controlling Authorities are designated as differently in different states, mostly Drug Controller along with Director, Drug Control Administration, Office-in-charge, Drug Control etc in some states. Drug Inspectors (DI) All Drug Inspectors are public servants under the Section-21 of the Indian Penal Code (IPC) & work under the Drug Controlling Authority under State Govt. or Central Govt. The Inspectors may be appointed either to inspect licensed premises for sale of drugs or to inspect the establishments licensed for the manufacture of both drug & cosmetics . Inspectors are required to keep all information acquired by them, in the course of their duty, confidential & not disclose it except for official purposes or when required to do before the court of law . (Cont.)   26

27. No persons having any financial interest in the import or manufacture or sale of drugs & cosmetics can be appointed as Drug Inspector under the Act. Qualifications of Drug Inspectors For appointment as Drug Inspector, a person must have a degree in Pharmacy/ Pharmaceutical Chemistry/Medicine with specialization in Clinical Pharmacology/Microbiology from a recognized University. For inspection of manufacture of substances in Schedule-C, the DI must have: At least 18 months experience in manufacture of at least one of the substance specified in the Schedule-C. At least 18 months experience in testing one of the item in the schedule-C. Experience of not less than 3 years in inspection of firms manufacturing any of the substances of the Schedule-C during their service tenure as DI. 27

28. Powers of Drug Inspectors Can inspect any premises wherein any drug or cosmetic is being manufactured and the means employed for standardizing and testing the drug or cosmetic. Can inspect 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 exhibited or offered for sale or is being distributed .  Take samples from any person who is in the course of conveying , delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee . At all reasonable times with necessary assistance, search any person, who has secreted about any drug or cosmetic in respect of which an offence relating to manufacture, sale or distribution has been or is being committed. (Cont.) 28

29. Can enter and search any place in which he has reason to believe an offence relating to manufacture, sale or distribution of drugs or cosmetics has been, or is being committed. Can stop and search any vehicle, vessel, or other conveyance which, he has reason to believe, is being used for carrying any drug or cosmetic in respect of which an offence has been, or is being, committed, and order in writing the person in possession of the drug or cosmetic not to dispose of any stock that of for a specified period not exceeding 20 days or, unless the alleged offence is such that the defect may be removed by the possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and any substance or article by means of which the offence has been or is being, committed. (Cont.) 29

30. Can examine any record, register, document or any other material object with any person or in any place mentioned above and seize the same if it is likely to furnish the evidence as an offence. Can require any person to produce any record, register, or other document relating to the manufacture for sale or for distribution of any drug or cosmetic in respect to which an offence has been committed exercise such other powers as may be necessary for carrying out the purposes of the Acts or Rules. Duties of Drug Inspectors Inspection of premises licensed for sale Inspect not less than twice in a year all establishments licensed for sale of drugs within the area assigned to the Drug Inspector and to e satisfied that the conditions of license are being observed. (Cont.)   30

31. Procure and send for tests or analysis, if the Drug Inspector has reason to think that the drugs are sold in contravention of provisions of the Acts or Rules. To investigate any complaints made to the Drug Inspector in writing & to institute prosecutions in respect to the contravention of the Act or Rules. To institute legal proceedings in case of any breach of the Act or the Rules. To maintain all records of inspections made & actions taken by him/her including taking of samples and seizure of stocks & to submit copies of such records to the Controlling Authority . To make enquiries and inspections as may be necessary to detect sale of drugs in contravention to the Act or Rules. When so authorized by the State Governments to obtain imported packages to suspect for containing drugs whose import is prohibited under the Act or Rules. 31

32. Inspection of Manufacture of Drugs   Inspect not less than twice in a year all premises licensed for the manufacture of drugs within the area allotted to the Drug Inspector and to be satisfied that the condition of license and provisions of Acts and Rules are observed.  In establishments licensed to manufacture products specifies in Schedule C and C1 inspect the process of manufacture, means employed for standardizing and testing of drugs, methods & place of storage, technical qualifications of staff employed & all details of location, construction & administration of establishment likely to affect the potency or purity of drug. To send Controlling Authority after each inspection a detailed report indicating conditions of license & provisions of Acts & Rules which are being observed & which are being not observed .  (Cont.) 32

33. To take samples of drugs manufactured on premises & send them for test or analysis.  To institute prosecutions in respect of breaches of the Act or Rules . Procedure of Drug Inspectors For taking samples of drugs & their despatches to the Govt Analysts An Inspector taking any samples must pay its fair price & may require written acknowledgement for the same. If price tendered is refused or when Inspector seizes any stock of any drug or cosmetic, he/ she should issue the receipt for the same. The Drug Inspector should inform the concerned person, the purpose of taking the sample & divide the sample to four parts in his presence. Each portion is then sealed & suitably marked. The person from whom the sample is taken must also be allowed to add his mark of seal on the packet. If sample taken from a manufacturing premises , it should be divided to three portions only. (Cont.)     33

34. If the sample is made into small volume is likely to deteriorate, the Drugs Inspector can take three or more containers when necessary after suitably marking it. One portion of sample is to be restored to the person , second part send to Government analyst and third one is preserved for production before the court , if required & fourth is sent to warrantor if any. Inspector should send sample to Government Analyst for the purpose of analysis of seized materials by registered post or by hand in sealed packet enclosed together with memorandum. If the confiscated drug is not of standard quality , it should be reported to court accordingly & court may order destruction of drug under the supervision of the Drug Inspector in presence of such authority that the court may prescribe. If confiscated drug is of standard quality , the Drug Inspector may report court accordingly and court may order sale of drugs by public auction to any party holding a requisite license. 34

35. For entry & search etc. of places, persons, vehicles, vessels etc. Every person for time being in charge of any premises where any drug or cosmetic is manufactured or is kept for sale or distribution, on being required by the Drug Inspector is legally bound to disclose to the inspector the place where drug or cosmetic is being manufactured or kept. Wilfully obstructing the Drug Inspector or refusing to provide any record or register is punishable with imprisonment up to three years or with fine or both . Forms or Memorandums used by the Drug Inspectors Form 15 : Order given by the Inspectors requiring a person not to dispose of any stock in his possession. Form 16 : Receipt by the Inspectors tender fair price for the seized material. Form 17 : Intimation to the person from whom sample is taken & purpose of taking sample. Form 17-A : Receipt of samples of drugs/cosmetics taken where fair price is tendered. Form 18 : Memorandum sent to the Govt. Analyst for the purpose of analysis of seized materials.   35

36. For seizure of stocks Any record, register or any other document seized by the Drug Inspector should be returned to the persons from whom they were seized or who produce the same within a period of 20 days of such seizure or produce after making copies, extracts etc. if necessary. When the Drug Inspector seizes any record, register or document, or any other material object, he should as soon as inform the same to the judicial magistrate & take his orders to the custody thereof. Customs Collectors (CC) The Custom Collectors are authorities established under laws other than the D & C Act, 1940 but they are charged with the administration of the D & C Act, 1940 to a certain extent. They are assigned some functions relating to control over the, import of drugs . 36

37. REFERENCES 37

38. References History of D&C Act, 1940. http://www.medindia.net/indian_health_act/drugs-and-cosmetics-act-1940 introduction.htm Drugs and Cosmetics Act, 1940. https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Act,_1940#Amendments Drugs and Cosmetics Rules, 1945. https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Rules,_1945 Ministry of Health and Family Welfare, GSR 588 (E) dated 30 Aug, 2013. Ministry of Health and Family Welfare, GSR 103 (E) dated 02nd February, 2017. Dr. B. S. Kuchekar. Pharmaceutical Jurisprudence. Pragati Books Pvt. Ltd. P.P 5.0–5.2. B. M. Mithal. A Text Book of Forensic Pharmacy. Vallabh Prakashan. 114-123. 38

39. Thank You 39