-The Hindu Study raises safety, efficacy concerns; call for ban of irrational formulations Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country’s drug regulator. In the case of malaria FDCs, only eight out of 20 (40%), have been approved. These statistics, that give rise to safety and efficacy concerns, have been brought...
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Centre bans 328 combination drugs in setback for pharma companies
-PTI The president of the Indian Drug Manufacturers' Association said the order would have an impact on a market worth an estimated 16 billion rupees a year for such drugs, which are produced by both small and large pharma companies. New Delhi: The Indian government has banned 328 combination drugs in a blow to both domestic and foreign pharmaceutical firms, but the ban has been cheered by health activists worried about growing...
More »What's in a generic name? -George Thomas & S Srinivasan
-The Hindu The core issues are affordable access to medicines and their rational prescription and use The Medical Council of India (MCI) issued a circular on April 21 drawing attention to clause 1.5 of its regulations regarding the professional conduct of doctors: “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription of drugs.” Further, the circular said,...
More »Generic prescription hurdles
-The Telegraph New Delhi: Regulatory efforts to get doctors in India to prescribe medicines only through their generic names, initiated about 15 years ago, will need to overcome legal challenges and resistance from sections of doctors and the pharmaceutical industry, experts said. Senior pharmacologists and industry analysts have also said it will be misleading to presume that prescriptions with generic names will automatically translate into lower medicine bills for patients as studies...
More »Call to doctors to shun drug cocktails -GS Mudur
-The Telegraph New Delhi: A health consortium today questioned a decision by Delhi High Court earlier this week to quash the Centre's ban on 344 cocktails of two or more medicines and urged doctors across the country to stop prescribing them. The Jan Swasthya Abhiyan (JSA), the Indian section of the global People's Health Movement, said it was shocked at the judgment because there was "no scientific rationale" for the continued use...
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