Last week, the Union health ministry revised the National List of Essential Medicines (NLEM) raising the total number to 384 from 348 existed in the NLEM-2011. The new list will be operational with immediate effect requiring their price fixation by the National Pharmaceutical Pricing Authority. Currently, only 348 drugs are in the NLEM-2011 and are subject to price control as per the National Pharmaceutical Pricing Policy 2012. But, after the announcement of the DPCO 2013, it was felt that many life saving medicines including anti-cancer drugs, expensive antibiotics and drugs needed for organ transplantation have been left out of price control. In fact, the prices of a number of essential and non essential drugs have gone up after the notification of new DPCO. And the government already admitted this fact in an affidavit filed in court stating that the market value and share of medicines covered by new DPCO is just 18 per cent of the country's pharma market. The Central Drugs Standard Control Organization, therefore, decided to constitute a core committee some time back under the chairmanship of Dr. V. M. Katoch, former secretary of Department of Health Research for reviewing and revising the NLEM-2011. The core committee submitted its report to the government on December 9 and after examination of the report, the government accepted the recommendations of the committee and adopted the NLEM-2015. In the revised list, a total of 106 medicines have been added while 70 medicines have been deleted as per the proposal of the committee.
Now having revised the list, the NPPA has to start the process of fixing the prices of the newly included drugs at the earliest. As per the newspaper reports, some of these newly included drugs are for diseases such as cancer and HIV/AIDS and hepatitis C. In all therapeutic groups there are several drugs and their brands under circulation and entire therapeutic groups are not under DPCO. And many of the drugs under DPCO are also in combination with drugs which are outside price control. Almost 50 per cent of all drugs marketed in the country today are fixed dose combinations and they are not covered under DPCO. Thus the price fixation of new drugs is going to be a complex and sometimes a questionable exercise. The NPPA has been of the view for some time that there exists a huge inter brand price differences in marketing of branded generics which is indicative of a severe market failure. Different brands of the same drug formulation in the market are identical in terms of active ingredients, strength, dosage, route of administration and quality but vary significantly in terms of price. This problem still remains and patients are denied cheaper brands as the doctors usually prescribe costly brands of big companies. Therefore, the pricing policy followed now undermines the entire objective of making essential drugs affordable to the people. It is important that the price control has to be expanded to cover all combinations, additional strengths and dosages of all essential and life saving drugs.