The Drugs and Cosmetics (Amendment) Bill, 2013 incorporating some major changes in the D&C Act is scheduled to be introduced in the ongoing session of the Parliament. One of the main objectives of the Bill is to establish a Central Drug Authority on the lines of US FDA to centralise drug licensing in the country. The health ministry made its first attempt to establish CDA nearly six years ago but failed in the face of strong opposition from various quarters. The revised Drugs and Cosmetics Bill, is a comprehensive legislation for the drugs and cosmetics sector and has already been cleared by the Union cabinet. Apart from the CDA formation, the Bill also seeks to have a separate chapter on clinical trials sector containing strict penal provisions relating to the payment of compensation, registration and creation of ethics committees and other regulatory aspects currently followed as guidelines. It is not, however, certain whether the Bill will be passed this time in view of the current mess in both the houses of the Parliament.
The Union health ministry has been keen to centralize licensing for manufacture, sale, export and distribution of drugs in pursuance of the recommendations of the Mashelkar Committee for some years now. Need for centralizing the drug control administration was felt on account of the urgency in bringing some uniformity in enforcement of various drug rules. In India. a new drug is approved for marketing by CDSCO but issuing product licenses for its manufacture used to be done by various state drug administrations. Although all states and Union territories are having their own drug control departments, most of them do not have officials with sufficient competence to evaluate an application before a manufacturing license is issued. Yet, state governments are not in support of formation of CDA as that could take away a lot of powers from them. Without the support of the state governments and industry, it will be difficult for the health ministry to implement CDA even if the bill gets passed. Therefore, it is important that the health ministry needs to take the concurrence of most state governments and the industry once again before giving final shape to CDA considering the sensitive nature of the expected changes of the new system.