The proposed Drug and Cosmetics (Amendment) Bill, 2013, which aims to regulate import, export, manufacture and distribution of drugs apart from other policies, is likely to run into rough weather as the All India Drug Control Officers’ Confederation (AIDCOC) has raised objections to several aspects mentioned in the Bill.
Secretary general of the AIDCOC, Ravi Uday Bhaskar, stated that the move will encroach on the powers of state drug authorities as it seeks to centralise licensing powers of 17 critical category products with Central government. Pointing out the effects of the Bill, he said that it will affect challenges faced by consumers like spurious, substandard drugs and further it will cause delay in addressing grievances of people. Expressing reservations over the proposed Bill, the AIDCOC had submitted a representation to Rajya Sabha Secretariat in which they raised strong objections on various provisions dealing with health which comes under concurrent list in Constitution of India. “It will lead to contravening of Article 246,” said Uday Bhaskar.
He mentioned that the Bill seeks to form Central Drug Authority (CDA) headed by health secretary as chairman and Drug Control General of India as member secretary.
Then import, export of simple formulations like paracetamol will also come under the control of the CDA, apart from other policies, he said.
About the proposal to centralise licensing authority of 17 critical category products which form 80 per cent of drug products like cytotoxic drugs, anti-cancer drugs, parenterals, etc., Uday Bhaskar questioned “How can Central Drugs Standard Control Organisation (CDSCO), which has 90 per cent less manpower compared to all state drug authorities will be able to handle all the operations. At present, there are about 170 regulatory officers in CDSCO and 90 per cent of them are recruited recently about one year back. While about 3,000 regulatory officers in various states of the country, spread out in different parts of the nation have better understanding of operations with more than 10 years of experience.”