Indian drug companies have approached the government’s think tank Niti Aayog, seeking some changes in the recently floated draft drug pricing policy, industry insiders said.
Drug industry lobby groups such as Indian Pharmaceutical Alliance, Indian Drug Manufacturers Association and The Federation of Pharma Entrepreneurs have reached out to National Institution for Transforming India (Niti Aayog) with their apprehensions and suggestions in the hope that their message will reach the Prime Minister’s Office (PMO).
They hope that Prime Minister Narendra Modi can offer some tweaks that would take in account industry’s concerns over some key issues that they said the draft policy prepared by the department of pharmaceuticals has overlooked, industry insiders said.
Members of Niti Aayog are expected to meet the PMO with the industry’s concerns this week, they said.
The Rs 98,000-crore drug industry has mainly objected to three proposals in the draft policy floated last month: one drug one brand, curbing retailer margins, and mandatory bioavailability and bioequivalence (BA/BE) test for all drugs approved by state regulators and also future renewals.
The industry said the move to restrict companies from using different brand names for drugs with same active ingredient would affect the marketing reach and business prospects of drug companies.
Having different brand names gives accountability to the sales force, and doctors also prefer brand names to identify a product with appropriate therapeutic benefit, companies said.
“Abolition of brand names for single ingredient drugs will in fact discourage innovation as companies will be denied option to distinguish an innovative generic product from me-too generics,” Indian Pharmaceutical Alliance (IPA) said in its written note to Niti Aayog.
“To be credible, the policy should cite evidence to support its observation that “giving brand names to generic drugs hampers real innovation,” it said. ET reviewed a copy of IPA’s letter.
Drug companies have also objected to mandatory quality control BA/BE tests for all drugs, including for future renewals of manufacturing licenses.
Companies say the government should first establish ample BA/BE study centres and provide relevant infrastructure before introducing these requirements.
[Source: http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/pharma-majors-knock-at-niti-aayogs-doors-with-concerns-over-new-drug-policy/articleshow/60833922.cms]