Under pressure from different quarters including the Supreme Court over the impact of the new pharmaceutical pricing policy, the Union health ministry is planning to revise the National List of Essential Medicines (NLEM-2011) which forms the basis of price control regime.
The Health Ministry is learnt to have initiated steps to revise the list in accordance with the existing market conditions and usage of drugs by the patients. The Ministry may soon set up an expert group to suggest appropriate changes in the list of drugs so that the impact of the pricing policy could be reflected more effectively.
Though the government had implemented the National Pharmaceutical Pricing Policy (NPPP) and issued the Drugs Price Control Order (DPCO) 2013 outlining the mechanism for price fixing, the issue is still under the scrutiny of the Supreme Court. The SC is hearing a petition by NGO All India Drug Action Network which alleged that the market-based pricing policy had led to average ceiling prices in many cases higher than the market leader price.
As the main base for price fixation, the NLEM is also under pressure with many describing it outdated. According to official estimates, the turnover of NLEM medicines is over Rs.29,000 crore and hence covers 60 per cent of Rs.48,200 crore domestic market. But public interest groups point out that many of those drugs under the price control were not in the market for long.
Strengthening the case of the NGOs, the National Pharmaceutical Pricing Authority (NPPA) has also accepted its inability to gather information about many formulations under control. The NPPA has already revised the prices of over 300 formulations as per the new policy and the DPCO. The prices of around 650 medicines had to be revised as per the new policy which brought down 348 essential drugs under price control.
However, already the agency has found that it could not gather information about 55 formulations and could not hence fix the prices. Most of these formulations are believed to be out of the market already.
The NLEM is one of the key instruments in healthcare delivery system of a country which inter alia includes accessible, affordable quality medicine at all the primary, secondary, tertiary levels of healthcare. The first list was prepared and released in 1996. This list was subsequently revised in 2003 with 74 bulk drugs. The panel for existing list was set up in 2010 and the list came out in 2011.
According to the DPCO provisions, the government can revise the NLEM and the pricing will be controlled as per the list. “National List of Essential Medicines” means National List of Essential Medicines, 2011 published by the Ministry of Health and Family Welfare as updated or revised from time to time and included in the first schedule of this order by the Government through a notification in the Official Gazette,” according to the DPCO.