Faced with criticism internationally over quality of medicines produced in the country, the Drugs Controller-General of India has issued directions for taking prompt and strict action for any violation of quality, safety and efficacy. Drugs Controller-General G.N. Singh has asked the Central Drugs Standard Control Organisation to ensure that drugs, cosmetics and medical devices, manufactured, marketed, imported or exported, meet the quality parameters and safety provisions prescribed under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. Meanwhile, the Supreme Court on Friday issued notices to the Centre and Ranbaxy Laboratories Ltd. on a public interest litigation petition seeking cancellation of the company’s licence and a CBI probe against it for allegedly supplying adulterated drugs. Issues of quality of medicines exported from India, when referred for investigation, are required to be probed on top priority, and an interim report has to be submitted within 15 days and complete information will have to be made available to the DCGI within three months so that requisite facts are flashed in time to embassies and government agencies of the countries concerned.
“This will help in allaying doubts and misinformation about the quality of drugs exported from India,” Dr. Singh said. The regulator has also issued instructions that drugs be allowed into India only if they meet the requirements of the Act.
