Sharing his thoughts on NPPA, Mr KV Balasubramaniam, managing director, Indian Immunologicals, said, "The cost-based price control mechanism might create problems for the industry instead of offering essential medicines at reasonable price. However, market-based pricing, as it would be based on widely available market information would result in transparency and fair pricing and would also encourage more investment in innovation."

This new policy will also ensure continuous availability of price-controlled medicines by preventing drugs from going off the market on account of an non-viable manufacturing environment which happened in the case of cost-based pricing. This methodology will allow patients to benefit from access to innovation and introduction of new medicines, as the players will continue investing in research and development (R&D) which ultimately helps to provide the patients with advanced and more effective medicines, as opposed to cost-based pricing which is not a factor in the R&D and innovation efforts and costs undertaken by pharmaceutical players and patient access to good quality medicines and will significantly improve as manufacturers will be encouraged to invest in quality raw material and processes.

Biologicals listed in NLEM
With the cabinet approval of NPPA, 348 essential drugs listed in the NLEM 2011will come under the scope of price control, leading to reduction in prices. The Government of India is keen on using NLEM as one of the key instruments in balanced healthcare delivery system, which inter alia includes accessible, affordable and quality medicine at all the primary (P), secondary (S), and tertiary (T) levels of healthcare.

The NLEM was prepared after many rounds of workshops and meetings of the core committee headed by Dr YK Gupta, professor and head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi and taking the views of 87 experts of different disciplines from leading medical and pharmacy institutions of the country.

In comparison to NLEM 2003, the 2011 list has added 43 new medicines by removing 47 medicines. In NELM 2011, 181 medicines fall under the category of P, S and T, 106 medicines fall under the category of S and T while 61 medicines are categorized as T only.