Pharmabiz
 

TASK BEFORE NEW GOVERNMENT

P A FrancisWednesday, May 28, 2014, 08:00 Hrs  [IST]

One of the key priorities for the new government at the Centre under Mr. Narendra Modi is to activate two important Central ministries, namely health and chemicals & fertilizers. Many of the policy matters and bills concerning public health and welfare in these ministries were held up for years for want of decisive action from the top. In the case of ministry of chemicals & fertilizers, working has been deplorable for the last five years with the designated cabinet minister, M K Alagiri, not visiting the ministry even once in a year. Whatever negligible work carried out in this ministry was after consultation with the minister of state, Mr. Srikant Kumar Jena. The Union health minister Mr. Gulab Nabi Azad has been, however, available for consultations on policy matters. But many important decisions were not taken. Surprisingly, the former prime minister chose to not to take any action against the ministers who were inactive for years. One of the major policy reforms which got stuck for want of ministerial intervention was establishment of a Central Drugs Authority. The bill was originally drafted in 2007 for centralizing issue of licenses for manufacture of drugs in the country. The need for centralizing drug licensing was felt as the state drug authorities have been issuing licenses without any scrutiny of applications resulting in circulation of thousands of irrational and harmful combination drugs in the market.  Another bill, that is waiting for parliament approval is for the establishment of Biotechnology Regulatory Authority. HIV/AIDS Bill is yet another important bill awaiting government nod since 2006. The HIV/AIDS (Prevention & Control) Bill 2013 is still to be vetted by the Ministry of Law and Justice. There was no time frame kept for its introduction in the parliament. Establishment of an exclusive regulatory authority for medical devices is another proposal long pending with the health ministry. The use of medical devices for various health conditions has increased considerably during the last ten years in the country. But there is no competent authority to check the quality and prices of medical devices and that situation has led to marketing of substandard products getting into the market at exorbitant prices. Violation of the Drug Price Control Order by the pharmaceutical companies has been a serious challenge the Department of Pharmaceuticals (DoP) facing for some years now. The pharmaceutical companies owe to government more than Rs. 3000 crore for overcharging essential drugs. DoP has not been able to recover this amount as the cases relating to price violations are yet to be decided by various courts. Import of large quantities of substandard bulk drugs at very low prices and mainly from China has been another serious issue Indian pharmaceutical industry facing for some time. The Drugs Technical Advisory Board has already brought this matter to the notice of the Central Drugs Standard Control Organisation. Such undesirable imports can seriously affect public health as several companies are depending on imported bulk drugs for making formulations. Steady decline in the export of pharmaceuticals especially to the big markets like the US and Europe during last two years is yet another issue of great concern. These developed countries are reportedly trying to block Indian exports of generics just to protect large multinationals at the cost of poor patients there. These and many other issues have to be addressed by the new government on an emergency basis by appointing competent ministers.

 
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