The office of the Drug Controller General of India last week decided to add 219 more drugs to the Schedule H of the Drugs and Cosmetics Act. The decision is a sequel to the recommendation made by the Drug Technical Advisory Board in this regard. With the addition of 219 drugs, the total number of drugs coming under the Schedule H stands at 453 now. The revision of the list of drugs under prescription is taking place after a gap of eight years. What has prevented DTAB to periodically recommend inclusion of prescription drugs under Schedule H is not very convincing. DCGI has, however, decided that henceforth all prescription drugs will be brought under the Schedule H as soon as they are approved for marketing in the country. That would mean the list of drugs under Schedule H would be constantly expanding considering the rate at which new drugs are being approved for marketing in India. While it is important to have newer drugs available in the country even at high prices, the efficacy and safety of many of these drugs are in doubt. One has to just look at the rate of withdrawal of new drugs from the US market after they are allowed to be marketed by the US FDA. Withdrawals of new drugs from the US market take place much faster and easier once they are found unsafe. The US FDA has no hesitation to ban a harmful drug or even for that matter by the pharmaceutical companies to withdraw the product from the market. In India, that is not the case. Once a drug is approved for marketing, it is almost impossible to withdraw it even if it is found harmful. Take the cases of Cisapride and nimesulide. Both are banned in many developed countries for their serious side effects but not in India. Manufacturers here, usually the big ones, put so much of pressure either on regulatory authorities or by moving court to keep any new drug in the market. Moreover, there is no practice of post marketing surveillance of new drugs by the pharmaceutical companies although it is mandatory since last two years. Genuine post marketing surveillance reports make it easier for the regulatory authorities to decide about the safety and efficacy of a new drug. Expansion of prescription list should therefore make physicians more careful and responsible while prescribing new drugs. And to have any meaning for the prescription list, the retail trade has to be disciplined. Today, no prescription is required to buy any medicines from the retail chemists anywhere in the country. Therefore, if the objective of placing critical drugs under Schedule H is to have a proper dispensation, then the laws have to be tightened to make pharmacies accountable.