Context

• National Pharmaceutical Pricing Authority (NPPA) has fixed ceiling prices of 355 medicines and 882 formulations for medicines under National List of Essential Medicines, 2015 (Schedule-I of DPCO, 2013).

Objectives of Drug Policy:

• As per the Modifications in Drug Policy, 1986 announced in September, 1994, the main objectives of the Drug Policy are as under :
  • ensuring abundant availability, at reasonable prices of essential and life saving and prophylactic medicines of good quality;
  • strengthening the system of quality control over drug production and promoting the rational use of drugs in the country;
  • creating an environment conducive to channelising new investment into the pharmaceutical industry with a view to encourage cost-effective production with economic sizes and introducing new technologies and new drugs; and
  • strengthening the indigenous capability for production of drugs.

Drugs (Prices Control) Order (DPCO)"

• The Drugs Prices Control Order, 1995 is an order issued by the Government of India under Sec. 3 of Essential Commodities Act, 1955 to regulate the prices of drugs.
• The Order interalia provides the list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by Govt., penalties for contravention of provisions etc.
• For the purpose of implementing provisions of DPCO, powers of Govt. have been vested in NPPA. Later, the Drugs (Prices Control) Order (DPCO) 2013 was notified.

About National List of Essential medicine:

• The decision about which medicines are essential remains a national responsibility based on the country’s disease burden, priority health concerns, affordability concerns etc. Ministry of Health and Family Welfare, Government of India hence prepared and released the first National List of Essential Medicines of India in 1996 consisting of 279 medicines.
• This list was subsequently revised in 2003 and had 354 medicines.
• Later in 2011, the list was revised and had 348 medicines. 
• Till June 2018, 851 medicines (including 4 medical devices i.e. Cardiac stents, drug eluting stents, condoms and intra uterine devices) are regulated under Revised Schedule - I based on National List of Essential Medicines, 2015 (NLEM, 2015). 

Purpose of the National List of Essential Medicines

The NLEM may have multiple uses. It can:

• Guide safe and effective treatment of priority disease conditions of a population
• Promote the rational use of medicines
• Optimize the available health resources of a country It can also be a guiding document for:
  • State governments to prepare their list of essential medicines
  • Procurement and supply of medicines in the public sector
  • Reimbursement of cost of medicines by organizations to its employees
  • Reimbursement by insurance companies
  • Identifying the ‘MUST KNOW’ domain for the teaching and training of health care professionals

About NPPA:

• National Pharmaceutical Pricing Authority (NPPA), was established on 29th August 1997 as an independent body of experts as per the decision taken by the Cabinet committee in September 1994 while reviewing Drug Policy.
• The Authority, interalia, has been entrusted with the task of fixation/revision of prices of pharmaceutical products (bulk drugs and formulations), enforcement of provisions of the Drugs (Prices Control) Order and monitoring of the prices of controlled and decontrolled drugs in the country.

Enforcement Authorities:

• The National Pharmaceutical Pricing Authority, the FDA/ Drugs Controller of the State, and Drugs Inspector of the District are the enforcing authorities at National / State/ District Levels.

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