CHAPTER II

LAWS RELATED TO DRUGS

1.      The Drugs and Cosmetics Act of 1940

       Main object of the Act is to regulate the import, manufacture, distribution and sale of  drugs and Cosmetics. Act extends to whole of India.

   1.       Act has provided for constitution of Drug Technical Advisory Board to advise the Central Government and State Government on technical matters arising out of administration of the Act and to other functions assigned to it."Act" lays down that, in case, offence is committed by a company, every personwho at the time of offence held charge and was responsible to the company shall be  deemed guilty. style="mso-spacerun: yes">  To be exonerated the person shall have to prove that the offence was committed without his knowledge or that he exercises all the diligence to prevent its commission.
2.Drugs Cosmetics Rules 1945 as Amended
Import, manufacture, sale and storage of drugs should be done under the valid license issued by respective licensing authority. Details of application forms, form in which licenses are granted, fee for grant/renewal to be paid, penalty to be paid if license is renewed after expiry but with in six months, are given in statement appended.(see Appendix A).

Good Manufacturing Practices (G.M.P.)
Good Manufacturing Practice is laid down under schedule M to the amended provisions of Drugs & Cosmetic Act and Rules is mandatory and has become as one of the conditions for grant and/or renewal of license. To achieve the objectives stated in schedule ' M' each license shall evolve methodology and procedures which should be documented and kept for reference and inspection.

Good Laboratory Practices
Good Laboratory Practices are necessary for product quality. GLP provides specific guidelines and concepts, which can serve as checks on various activities of the laboratory. This includes:

Premises:The premises shall be well lighted and properly ventilated, except nature of test warrant, otherwise. Whenever necessary, premises shall be air-conditioned to maintain the accuracy and functioning of laboratory instruments or carrying as sterility tests, microbiological tests, etc. Adequate space should be provided.

3. Import/Manufacture of “New Drug” for Test or Marketing

No new drug shall be imported or manufactured for clinical trials or marketing except under and in accordance with the permission in writing of Licensing Authority appointed by central Government Importer or manufacturer of new drug shall submit data as given in Appendix 1 of Schedule Y, including results of clinical trials carried out in accordance with guidance specified in Schedule Y and submit the report of such clinical trials in format given in Appendix II in Schedule.

  (Modifications in Drug Policy, 1986 by Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals)

 Introduction

1.The Drug Policy of 1996, which was titled “Measures for Rationalisation, Quality Control and Growth of Drug & Pharmaceutical Industry in India” was evolved under the dynamic guidance and leadership of late Shri Rajiv Gandhi. This was done after a detailed examination of the various issues. The main objectives of the Drug Policy, 1986 are as under:
a) Ensuring abundant availability, at reasonable prices of essential and life saving and prophylactic medicines of good quality;
5. Drug (Price Control) Order, 1995THE LIST OF 76 DRUGS

1.  Sulphamethoxazole            2. Penicillins                  3.  Tetracycline 4.  Rifampicin                           5.  Streptomycin
6. Ranitidine                   
6. Pharmacy Act was passed in 1948 and was amended in 1959 and 1976. The aim of Act

6). Pharmacy Act
(1) To provide uniform education and training of “Would be” Pharmacists and

(2) To maintain a control over persons by providing registration. Central council of Pharmacy is entrusted with duty of uniform education regulations while state pharmacy councils are concerned with registration of Pharmacists. Pharmacy Act extends to whole of India except state of Jammu & Kashmir.

7. The Drugs and Magic Remedies (Objectionable Advertisement) Act of 1954

This Act is meant to control the advertisements regarding drugs: it prohibits the advertising remedies alleged to possess magic qualities and to provide for matters connected therewith.

The Drug & Magic Remedies Act prohibits a person from taking part in the publication of any advertisement referring to any drug which suggests the use of the drug for: (a) the procurement of miscarriage in women or prevention of conception in men: (b) the maintenance or improvement of the capacity of the human being for sexual pleasure:

(c) the correction of menstrual disorder in women: (d) the diagnosis cure mitigation treatment or prevention of any general disease. It is prohibited to directly or indirectly give a false impression regarding the true character of a drug or make false claim of it or

  8.   The Narcotic Drugs and Psychotropic Substance Act, 1885