Reacting probably for the first time on the controversial issue of withdrawal of fixed dose combinations (FDC) from the market, Drugs Controller General of India (DCGI) Dr M Venkateshwarlu said that the combination drugs are a crime on society by the drug manufacturers of the country. "Now I am in a position to call the shots and I am determined to remove this crime from the society which has been going on for the last over 10 years," he said.

Lambasting the drug manufacturers for describing the DCGI decision to withdraw irrational combination drugs from the market as 'immediate and hasty', Dr Venkateshwarlu said that the debate on this issue has been going on for the last over 10 years in the country. "I was not in a position to take any action that time. Now I will call the shots," he said.

Over the issue of most of the combination drugs being described as irrational drugs, DCGI denied that he had ever described them as irrational. "There is ambiguity over the rationality, stability and efficacy of these drugs. Let them come to the DCGI and get overcome this ambiguity before marketing them," he said.

Deeply upset over the way the combination drugs have come to dominate the drug market in the country during the last over one decade, Dr Venkateshwarlu said in the initial stages it was a minor aberration which was harmless and nobody took notice of it. But things have now come to such a pass that the drug market is filled with combination drugs which are harmful to the patients. "It is a crime on society which I wanted to stop. That the doctors are prescribing these drugs are the sad part of this entire sordid saga," he regretted.

Refuting the Indian Drug Manufacturers Association's (IDMA) plea that the state drug authorities are empowered to issue licenses to FDCs as they do not fall in the category of new drugs under Rule 122 (E) (c) of Drugs & Cosmetics Rules, 1945, Dr Venkateshwarlu literally ridiculed the IDMA for being called the national association of drug manufacturers. "Any layman who reads these rules carefully can understand that the FDCs are new drugs under Rule 122 (E). If the IDMA says they do not fall under new drugs, then they don't deserve to be called a drug association," DCGI said.