DCGI Issues Notices To Streamline Granting Of Licenses

DCGI had issued a crucial notice under section 33(P) of the Drugs and Cosmetics Act, 1940 (“Act”) on October 12, 2012 to the health secretaries of all states in India to grant or renew manufacturing license of drug formulations in proper generic names only in order to streamline the regulatory practices followed by the state licensing authorities. Subsequently, Health Ministry issued clarification stating that the direction will not be applicable to the (i) exporters (various types of certificates, namely CoPP, GMP certificate, Free Sale Certificate, etc) and (ii) grant/renewal of licenses for import of drugs. It shall be applicable only for the manufacturing licenses issued by the drug licensing authorities. On a similar note, confusion on the said notice was removed when clarification from the Health Ministry provided that the approval for drugs will, henceforth, be granted by the state drug authorities only under generic names and the drug manufacturer has the freedom to manufacture the product under various brand names.

PSA view –  The clarifications were necessary to remove confusion regarding the issue of granting or renewal of manufacturing licenses of drug formulations under brand names by the state drug licensing authorities for the purpose of exporting as most of the state drug licensing authorities stopped issuing licenses in brand names, even for the purpose of exports. Now, pursuant to the second clarification, the brand names will not have the approval from the SLAs as brand name issue is a trade mark issue over which the state licensing authorities have no control. Creating such a distinction is a welcome step. 
Drug pricing policy still not finalized
  
In September 2012, the Supreme Court directed the Central Government to regulate the prices of essential medicines. The panel of ministers tasked with the mandate to finalize the country’s drug pricing policy met on September 27 to finalize a pricing policy and agreed on a policy which was sent to the Cabinet for approval. The policy that aims to bring 348 essential drugs under price control of the government was deferred due to certain objections from the Finance Ministry. In light of this, the group of ministers are expected to meet again towards the end of November 2012 and try to finalize the policy. The reasons for deferment are not known yet.
At present, the government through the National Pharmaceutical Pricing Authority controls prices of 74 bulk drugs and their formulations.
PSA view –  The policy has been long overdue. The Supreme Court had given the government an ultimatum of two weeks to finalize the pricing policy but this has still not been done. A balanced policy is the need of the hour as pricing of 348 essential drugs is dependent on this. A final policy is required and is required fast. 
 
By:
Neeraj Dubey
Divij Kumar