The much awaited Central Drugs Authority (CDA) Bill, that will issue licenses in 17 critical categories, is likely to be tabled in Parliament during the forthcoming winter session of Parliament which begins on November 24.

In August 2013, the CDA Bill was introduced in the Rajya Sabha but was passed on to the Parliamentary Standing Committee. Although the Committee has submitted its observations in December 2013, it had practically run into trouble as some of the key suggestions were unacceptable.

It is gathered from sources that the new government under Prime Minister Narendra Modi is keen to push the CDA Bill through. The sector has clocked a 12-14 per cent consistent growth rate with $23 billion (Rs.1.38 lakh crore) turnover in fiscal 2014 which indicates the importance of  this industry.

“This Bill will now include the approval for medical devices which is a vital in the current context of a fast transforming healthcare landscape. Another point is that licenses to be issued for the manufacture of blood products and vaccines that so long came under the state drugs control department purview and counter signed by the Drugs Controller General of India will now cease to require such approvals. Instead the DCGI will have total control of issuing the production licenses for these products,” stated sources.

According to Dr DBA Narayana, an eminent pharmacist and member of the Mashelkar Committee, if the Union government introduces the revised draft of the Central Drugs Authority Bill with a revision in its nomenclature as Central Drugs Administration with the recommendations of Dr. RA Mashelkar being incorporated, then it is a step in the right direction. But if the Bill is passed as Central Drugs Administration with change in the regulatory regime, then I am afraid it loses its significance in the current context which demands a sound system in place.