Government revised National List of Essential Medicines

• The Ministry of Health and Family Welfare has released the National List of Essential Medicines (NLEM) 2021 added 39 drugs including anti-cancer, anti-diabetes and antiretroviral drugs to the list.
• 16 drugs also have been removed from the list of NLEM 2015.
• In August 2021, the government has amended the mandatory provision of price revision of the Drugs (Prices Control) Order, 2013.

Essential Medicines:

• According to World Health Organisation (WHO), Essential Medicines are those that satisfy the priority health care needs of the majority of the population.
• Every country prepares essential medicines list to address the disease burden of the nation and the commonly used medicines at primary, secondary and tertiary healthcare levels.

National List of Essential Medicines (NLEM):

• It was prepared first by the health ministry in 1996 consisting of 279 medicines.
• The Ministry of Health and Family Welfare prepares the National List of Essential Medicines of India which is a list of drugs eligible for price regulation.
• Then the Department of Pharmaceuticals, which comes under the Ministry of Chemicals and Fertilizers, incorporates them into Schedule 1 of DPCO.
• After that, the Standing Committee on Affordable Medicines and Health Products (SCAMHP) examines the list of drugs they will advise the drug price regulator the National Pharmaceutical Pricing Authority (NPPA).
• The NPPA then fixes the prices of drugs in this Schedule.
• Currently, around 374 medicines are listed in the NLEM which are subject to price controls.
• About 18 per cent of the drugs sold in India are under price controls.
• Every five years, the National List of Essential Medicines is revised and the ceiling prices of the drugs are fixed.

Drug Prices and Control Order (DPCO), 2013:

• It was issued under Section 3 of the Essential Commodities Act, 1955.
• The DPCO allows the government to declare a ceiling price for essential and life-saving medicines.
• Price controls are applicable to those medicines which are listed in Schedule I of DPCO.

National Pharmaceutical Pricing Authority (NPPA):

• It was set up as an attached office of the Department of Chemicals and Petrochemicals (now Department of Pharmaceuticals) in 1997.
• NPPA was established to implement and enforce the provisions of the Drugs Price Control Order (DPCO), 2013.
• The authority is responsible for regulating the prices of drugs in the country and ensuring their availability, accessibility and affordability to every citizen of the country.

Functions:

• To monitor the availability of drugs, identify shortages, if any, and take remedial steps.
• To collect and maintain data on production, exports and imports, market share of individual companies, the profitability of companies etc. for bulk drugs and formulations.
• To deal with all legal matters arising out of the decisions of the Authority.
• To render advice to the Central Government on changes/revisions in the drug policy.