A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion The health ministry has denied the presence of any systemic rot in the drug approval process and pharmaceutical firms have refuted charges of collusion after a report by a parliamentary panel pointed to regulatory lapses in clinical trials. The panel, which looked into the functioning of Central Drugs...

-The Hindu Business Line The onus of granting approvals to medicines marketed in the country is on the regulator Drug Controller General of India (DCGI), say drug companies, adding that they have adhered to the law of the land. The drug-makers were responding to a Parliamentary panel report on health that severely indicted the drug regulatory authority, besides alleging that “invisible hands” of drug-makers were involved in getting favourable reports on medicines...

-PTI German pharma major Bayer has charged that Indian generic drugmaker Cipla had breached its patent rights by slashing the price of a generic version of its patent-protected cancer drug Nexavar last week. Bayer Pharma has not given its consent to Cipla to launch its generic Sorafenib (sold under the brand name Nexavar) and the company’s decision to cut the price of the life-extending kidney and liver cancer drug “is a clear...

The debate about essential-medicine pricing and access in India illustrates the difficulties inherent in establishing policies that serve conflicting public interests in achieving goals such as caring well and ensuring safety for all, while also pursuing financially-sustainable success in scientific innovation and trade. It highlights problems facing those interested in continuing drug and vaccines development and ensuring that, once marketed, such products contribute effectively to improving public health. Modern pharmaceuticals...

A report by a parliamentary committee has shown that the drug industry regulator, the Drug Controller General of India (DCGI), has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion—findings that expose the deep flaws prevalent in India’s drug approval process. The committee has asked the health ministry to withdraw the discretionary powers given to the Central Drugs Standard Control Organization...