Question

Summarize at least two key pieces of legislation that govern the pharmaceutical industry.

Answer 1

As per the section 92A of the Indian Patent Act, Compulsory License shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory license has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical product from India.

Promulgation of the Drugs (Display of Prices) Order, 1962 and the Drugs (Control of Prices) Order, 1963 under the Defense of India Act was an initiative, under which the prices of drugs were frozen w.e.f. the 1st April, 1963. The Drugs (Prices Control) Order of 1966, the Drugs (Prices Control) Order of 1970 – issued under the “Essential Commodities Act 1955 by declaring drugs to be essential commodities under the EC Act, 1955. The government has been dismissing these concerns by citing drug price regulations and compulsory licensing as tools to tackle the problem of high prices. There is also the Drug Price Control Order administered by the National Pharmaceuticals Price Authority. Our team works for infringement of Intellectual Property rights of an unregistered trade mark, besides that we also assist our client in compliance of laws and regulations.