Safety of pharmaceutical products marketed by drug companies is being increasingly scrutinized by regulatory authorities world over in the wake of frequent reports of their serious side effects even after they are in market for years. Withdrawal of some of the blockbusters of top MNCs from the market during last couple of years for causing adverse drug reactions and detecting presence of higher levels of impurities is a result of this growing concern. Pharmaceutical manufacturing is a highly complex process requiring utmost care and caution. Any manufacturing fault in the product can have fatal effect on the patients jeopardising their very lives. The reason for introducing more and more stringent manufacturing standards in this industry is in the context of lapses on the part of drug companies. Unfortunately, in India the pharmaceutical industry has been hesitant to adopt even basic manufacturing standards forcing the government to intervene. Take the case of GMP implementation. Several thousands of pharmaceutical units are still opposing introduction of Schedule M norms in their manufacturing facilities despite these norms were made part of the Drugs & Cosmetics Act. Although a good number of small pharmaceutical units were forced to close down for not complying with the Schedule M norms, there are still hundreds of units in the country selling pharmaceutical products without adhering to good manufacturing practices. This cannot be allowed any more and it is high time that the state drug control authorities achieved total compliance of the norms in their states.
Adopting higher standards in pharmaceutical manufacturing is the need of the hour for the Indian pharmaceutical industry especially when it is emerged as an international player. The decision of the Indian Pharmacopoeia Committee to introduce a chapter on impurity standards for APIs and dosage forms in the new edition of Indian Pharmacopoeia is with this objective. The new chapter will have specifications on levels of identified impurities, unidentified impurities and their total allowable levels for the drug substances. The chapter in the Pharmacopoeia will specify acceptance criteria for degradation of substances in drug products. Information on impurities associated with toxic reactions, including genotoxicity, will be included in the chapter so that specific tests can be added in existing or new monographs of Indian pharmacopoeia. The new approach is intended to help the Indian companies in global market with an effort to move close to the acceptance criteria for impurities in drug substance as per the internationally harmonised standards. Ranbaxy has already faced a problem in this regard last month in the US market when it had to withdraw 73 million gabapentin tablets for higher impurity levels. Right from its formation, IPC has been giving special attention to the methods of manufacture used by the indigenous industry in selecting the pharmacopoeial tests for monitoring the toxic impurities of any drug. Now, inclusion of a specific chapter on impurity standards in IP is going to be extremely useful for the export oriented pharmaceutical units. In fact, it is important that these impurity standards and limits should be made mandatory for the entire pharmaceutical industry without much delay.