-The Times of India NEW DELHI: In a move that comes as a huge relief to patients of chronic Hepatitis C, the apex committee of the Central Drugs Standard Control Organisation (CDSCO) has granted a waiver of local trials for crucial new direct-acting antiviral drugs treating the disease. The waiver for sofosbuvir and ledipasvir co-formulation and for daclatasvir is expected to bring the generic version of these drugs, which cost a fraction...
More »SEARCH RESULT
Government eases norms to test, launch drugs -Sushmi Dey
-The Times of India NEW DELHI: In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved in other countries. Pharmaceutical companies planning to launch new drugs already approved outside India after conducting pre-clinical or toxicological studies on animals will not be required to repeat such studies in...
More »Politics of Immunisation
-Economic and Political Weekly The health ministry's move on HPV vaccine feasibility is ill-advised. The union health ministry has asked the National Technical Advisory Group on Immunisation (NTAGI) to examine the feasibility of introducing the Human Papillomavirus (HPV) vaccine in the country’s universal immunisation programme. The NTAGI has been given three months for this task. The HPV vaccine, which is supposed to protect against cervical cancer in girls and women, is generally...
More »Health ministry moots online sale of drugs; regulator works on guidelines -Sushmi Dey
-The Times of India NEW DELHI: As online shopping catches up, you could buy medicines too with a click of the mouse for which the health ministry is evaluating a proposal. The drug quality regulator is framing guidelines and mechanism to monitor such sale. The proposal is expected to be taken up for discussion in the drugs consultative committee meeting next month, a senior regulatory official said. At present, the Drugs & Cosmetics...
More »Govt may negotiate price of drugs before market entry -Sushmi Dey
-The Times of India NEW DELHI: The government may negotiate prices of patented medicines with their manufacturers before allowing pharmaceutical companies to launch them in India. The move, a first of its kind, is also likely to be applied on patented drugs that are already being sold in the country, an official source said. An inter-ministerial committee, evaluating the mechanism to negotiate prices of patented medicines, has recently sought detailed information about...
More »