Non-scheduled drugs

• Non-scheduled drugs are pharmaceutical products that do not fall under any specific schedule of the Drugs and Cosmetics Act or the National List of Essential Medicines (NLEM).
• They are not subject to government price control.
• The manufacturer of a non-scheduled drugs  is not required to take price approvals from NPPA for such drugs. 
• However, NPPA is required to monitor the prices of such drugs and take corrective measures where warranted and that includes the power to fix and regulate such prices.

Trade Margin Rationalisation (TMR)

It refers to the policy of capping and regulating the difference between the selling price of a drug (or medical product) and its procurement or manufacturing price, in order to prevent excessive mark-ups across the supply chain and ensure affordability for consumers.

• Department of Pharmaceuticals (DoP): Functions under the Ministry of Chemicals and Fertilizers and oversees pharmaceutical policy and pricing.
• National Pharmaceutical Pricing Authority (NPPA): An independent authority under the DoP responsible for implementing and enforcing the Drugs (Prices Control) Order.
• Drug (Prices Control) Order, 2013:  Regulates medicine prices using the National List of Essential Medicines (NLEM) as the basis for ceiling price fixation for scheduled drug.
  • DPCO is issued by the Government of India under the Essential Commodities Act, 1955 to regulate the prices of essential medicines.
• National Pharmaceutical Pricing Policy (NPPP), 2012: Aims to guarantee the availability of essential medicines at reasonable prices through a structured pricing framework.
• NITI Aayog’s Role: 
  • Through its Standing Committee on Affordable Medicines and Health Products (SCAMHP), NITI Aayog advises NPPA on pricing of drugs and health products.
  • It does not directly participate in price fixation.
• Central Drugs Standard Control Organisation (CDSCO): It functions as India’s national drug regulatory authority, responsible for regulating the safety, efficacy, and quality of drugs, vaccines, medical devices, and cosmetics.
• Drugs Controller General of India (DCGI): The DCGI serves as the chief regulatory officer who approves new drugs and medical devices, authorises clinical trials, issues manufacturing licences for certain drug categories.