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Introduction

1. The Drug Policy of 1986, which was titled “Measures for Rationalization, Quality Control and Growth of Drugs Pharmaceuticals 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 :

ensuring abundant availability, at reasonable prices of essential and life saving and prophylactic medicines of good quality;
strengthening the system of quality control over drug production and promoting the rational use of drugs in the country;
creating an environment conducive to channelising new investment into the pharmaceutical industry to encouraging cost-effective production with economic sizes and to introducing new technologies and new drugs; and,
strengthening the indigenous capability for production of drugs.
2. For meeting the requirements of medicines for health needs at reasonable prices and strengthening the indigenous base the Government has, over the years been guided by the above Policy. Implementation of the main policy provisions has been through the I(D&R) Act on Industrial Licensing aspects and through Drugs (Prices Control) Orders under the Essential Commodities Act in regard to the pricing mechanism. The Drug Policy has also given the policy framework in regard to Quality Control and Rational Use of Drugs. Enforcement of quality and standards in medicines is done through the provisions contained in the Drugs & Cosmetics Act, which is administered by the Ministry of Health and Family Welfare.