NDPS drugs Regulation and Licensing PPT.pptx

Knowledge of regulation and licensing of NDPS drugs used as medicines is important. It is imparative for the State to endeavour to bring about prohibition of the consumption, except for medicinal purposes, of intoxicating drugs injurious to health. Such substances which are used as medicines, dual regulations viz., NDPS Act and Drugs Act and Rules come into play in India.

1. Regulation and Licensing of manufacture and sale of Psychotropic Drugs Dr Sanjay Pareek Asst. Drugs Controller , Rajasthan

2. Importance of Regulation Directive Principles, contained in Article 47 of the Indian Constitution, direct the State to endeavour to bring about prohibition of the consumption, except for medicinal purposes, of intoxicating drugs injurious to health . The National Policy on Narcotic Drugs and Psychotropic Substances flows from this constitutional provision.

3. Importance of Regulation The government’s policy on the subject is also guided by the international conventions on the subject . India is a signatory to the single Convention on Narcotic Drugs 1961, as amended by the 1972 Protocol , the Conventions on Psychotropic Substances, 1971 and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.

4. Central Acts The broad legislative policy is contained in the three Central Acts, viz. Drugs and Cosmetics Act, 1940 The Narcotic Drugs and Psychotropic Substances Act, 1985 The Prevention of Illicit Traffic in Narcotic Drugs and Psychotropic Substances Act, 1988. The responsibility of drug abuse control, which is a central function, is carried out through a number of Ministries, Departments and Organisations of Centre and State Govt.

5. So much focus on the subject is because of the problem of Drug abuse

6. Regulation Narcotic drugs and psychotropic substances can be manufactured, imported into/ exported out of India subject to specific Rules under Chapter VI and VII of Narcotic Drugs and psychotropic substances Rules, 1985. Stringent guidelines have been laid down by the Govt to ensure that their sale and manufacture is regulated.

7. Manufacture of psychotropic substances Rule 64 (NDPS)- Manufacture of psychotropic substances.-(1) No person shall manufacture any of the psychotropic substances except in accordance with the conditions of a licence granted under the Drugs and Cosmetics Rules, 1945 framed under the Drugs and Cosmetics Act, 1940, by an authority in-charge of Drugs Control in a State appointed by the State Govt in this behalf .

8. Manufacture of psychotropic substances Manufacture of Bulk drugs would invoke additional provisions of Rule 64 (2), (3) and Rule 65. (wherein the drugs Controller shall consult the Narcotics Commissioner with regard to the assessed annual requirements)

9. Sale, purchase, consumption or use of psychotropic substances. Rule 65(A) [NDPS] - No person shall sell, purchase, consume or use any psychotropic substance except in accordance with the Drugs and Cosmetics Rules, 1945 Provisions of Part VI under the Drugs Rules have to be complied with.

10. Transport of psychotropic substance Rule 67 (NDPS) – No consignment of psychotropic substance unless accompanied by a consignment note in Form 6 Provided that consignment note in Form 6 shall not apply in cases where the sale of the psychotropic substance is accompanied by a sale bill or invoice or a cash memo.

11. Psychotropic Drugs covered under Sch H or H-1 of Drug Rules Sl. no. in the Sch of NDPS Act Sl. no. of Drug in Sch H or H-1 30 Alprazolam 1 Sch H-1 36 Chlordiazepoxide 18 Sch H-1 43 Diazepam 22 Sch H-1 50 Flurazepam 207 Sch H 56 Lorazepam 294 Sch H 64 Nitrazepam 36 Sch H-1 66 Oxazepam 371 Sch H 69 Phenobarbital 396 Sch H 92 Buprenorphine 3 Sch H-1 100 Midazolam 34 Sch H-1 110Y Tramadol 45 Sch H-1

12. Import, Export of NDPS Drugs Rule 53 (NDPS) - Import into and export out of India of the narcotic drugs and psychotropic substances is prohibited except with an import certificate or export authorization issued under the provision of Chapter VI.

13. Applicability of D&C Act and Rules Such Psychotropic drugs which are included in the Schedule of NDPS Act and are used for medicinal purpose also, can be manufactured and sold in accordance with the conditions of a licence granted under the D&C Act and Rules.

14. Sale of Sch H and H-1 drugs Rule 65 (Drugs Rules)- Substances specified shall not be sold by retail except on and in accordance with the prescription of a RMP. The supply of drugs to RMP, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for 2 years.

15. Sale of Schedule H-1 drugs The supply of such drug shall be recorded in a separate register at the time of supply giving the name and address of the prescriber, name of patient, name of the drug, quantity supplied. Such records shall be maintained for 3 years and be open for inspection.

16. Drugs supplied by a Registered Medical Practitioner to his own patient License not required ( Sch K, Rule 123 Drug Rules), subject to conditions: The drugs shall be purchased only from a dealer licensed under these Drugs Rules, and records of such purchases shall be maintained. Such records shall be open to inspection by an Inspector. The name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed, the name of the patient & the date of supply and the name of the person who gave the prescription shall be entered at the time of supply in register to be maintained for the purpose.

17. Contd … The entry in the register shall be given a number and that number shall be entered on the label of the container; The register and the prescription, on which the medicines are issued shall be preserved for not less than two years.

18. Labelling Requirement Rule 97 (Drugs Rules) - If the container of the medicine contains a substance specified in Sch H-1 and comes within the purview of NDPS Act 1985 be labeled with the symbol NRx , which shall be in red on the left top corner . There will be Sch H1 warning in rectangular box. -It is dangerous to take this preparation except in accordance with the medical advice. -Not to be sold by retail without the prescription of a Registered Medical Practitioner.

19. Essential Narcotic Drugs (ENDS) NDPS Ammendment Bill 2014 was passed with path-breaking changes for access to narcotics by medical specialty by adopting a new category of Essential Narcotic Drugs. Name of Drug 1 Fentanyl 2 Hydrocodone 3 Methadone 4 Morphine preparations 5 Oxy- codone

20. Thanks