Pharmaceutical Drug Manufacturers

13 May 2010-
The government of India has drafted a comprehensive national vaccine policy that proposes to bring all types of vaccines under the Drugs Price Control Order (DPCO) and targets at enabling rational and evidence-based decisions for the development, entry, production, stable supply, pricing, promotion and use of appropriate vaccines on scientific grounds.

Read about Drugs Price Control Order (DPCO)

According to the draft national vaccine policy, the public sector would be the sole manufacturer of key vaccines so that stable and affordable supply of vaccines for the national immunization programme can be ensured. This will also be helpful in managing national health security and biosecurity concerns. Therefor, all essential vaccines covered under UIP (TT, DT, DTP, BCG, polio, measles) would continue to be produced by the public sector. The draft national vaccine policy also ensures that at least two functional PSUs produce a kind of vaccine so that both of them can act as a backup for each other, in case there occurs any kind of market uncertainties. The draft vaccine policy further states that pricing of vaccines should be done on a transparent basis and agreed principles of reasonable returns on investment, rates of royalty and costing of R&D efforts. There should be no overhead taxes imposed on vaccines like those of excise duty, value added tax (VAT), customs duty etc. The difference between maximum retail price (MRP) and the price at which vaccines are supplied to pharmaceutical wholesalers, retailers, hospitals or even to doctors will also be minimized to deter monetary incentives for unethical vaccine promotions.

The draft vaccine policy also talks about the vaccines outside the UIP. It says that such vaccines should not be unethically promoted through direct or surrogate advertising, advocacy by individuals, groups or aid agencies, on their own or funded directly or indirectly by the vaccine industry. Further, publicly funded R&D on vaccine technologies should be made available widely on a non-exclusive basis to promote production of quality vaccines at competitive prices.

Vaccine Development in India

Vaccine development in India that had a slow start, is now a full fledged activity within the pharmaceutical industry. Now the nation is not dependent on imported vaccines for its immunization programmes. India, due to the progress of indigenous vaccine development has not only become self-sufficient in vaccines manufacturing according to international standards, but has also become a key vaccine supplier of the same to UNICEF. Vaccine development here is regulated by a hierarchy of regulatory bodies. The Indian Council of Medical Research (ICMR) guidelines set the rules of conduct for clinical trials of vaccines from Phase I to IV studies as well as studies on combination vaccines. ICMR guidelines also address ethical issues that arise during a vaccine study. A network of Adverse Drug Reaction (ADR) monitoring centers along with the Adverse Events Following Immunization (AEFI) monitoring program makes up the machinery for vaccine pharmacovigilance.