Pharmabiz
 

AGENDA FOR AZHAGIRI

P A FrancisThursday, July 23, 2009, 08:00 Hrs  [IST]

After a full term of indecision on various policy matters, the Union chemicals ministry has now got a new minister to look after the affairs of the pharmaceutical industry. M.K. Azhagiri, the new minister with no previous experience in the Central government and not much knowledge of the pharmaceutical sector, has a tough time ahead with a large number of issues to be understood and settled. The first item in his agenda is the finalization of the long delayed new pharmaceutical policy pending for last seven years. The Group of Ministers headed by Sharad Pawar was to finalize the policy during the last term of the UPA government. That did not happen. Now a new GoM has to be constituted by the Cabinet to finalize the policy draft. It is possible that new GoM may be announced in a few days from now. The new minister has already indicated that he would not make any changes to the draft made by the earlier GoM before sending it to the new GoM. The aim of the policy draft was to bring price control over a larger basket of drugs in place of the existing controlled list of just 74 drugs as per the 1995 Drug Price Control Order. After the 1995 DPCO was notified, several new drugs were approved for marketing for existing diseases and various new indications by the DCGI. Although many of them were essential drugs and marketed at high prices, there has been an unexplained hesitation on the part of the National Pharmaceutical Pricing Authority to include them under DPCO. The GoM headed by Sharad Pawar was to take care of this matter in the new Pharmaceutical Policy. Now, Azhagiri has also indicated his intention of bringing more drugs under the DPCO to make life saving drugs affordable to larger sections of the people. Collection of over Rs 2000 crore from 471 pharmaceutical companies for overcharging price controlled drugs is another mammoth task before the minister. NPPA has sent notices in 660 cases so far after its inception to these companies for recovering around Rs 2003 crore. It could recover about Rs 164 crore so far from the defaulters, as the rest of the amount as pending because of litigations in various courts. A mechanism has to be worked out not to further accumulate the arrears from the companies. Formation of a Central Drug Authority for streamlining the drug control administration in the country was another key reform that remained unimplemented during the last term of the ministry. Although this is a regulatory issue falling under the jurisdiction of the health ministry, Azhagiri has to take a position as it directly affects drug manufacturing activity. In the absence of a centralised drug control machinery, manufacturing licenses are being issued by various state drug authorities with no proper coordination with DCGI or other state drug bodies. This is causing an uncontrolled growth of products containing same ingredients and combinations by a large number of companies. Many of these products are harmful with no therapeutic rationale. A centralised licensing system is expected to bring some order to this chaotic situation of today. It is possible that the bureaucrats in the Department of Pharmaceuticals might have already briefed the minister about all the pending decisions. What is required now is the active support and guidance of the officials in the Department to enable the minister to execute these policy decisions at the earliest.

 
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