The Ministry of Chemical and Fertilizers (MOCF) on July 30, 2024, notified regarding the monitoring of prices by NPPA of scheduled and non-scheduled medicines under the Drugs (Prices Control) Order, 2013.It states that action shall be taken against companies, found selling formulations at prices higher than the permissible price, and the overcharged amount recovered from the company as per the relevant provisions of the Drugs (Prices Control) Order, 2013.
Categorization of Formulations
DPCO, 2013, classifies pharmaceutical formulations into two categories:
- Scheduled Formulations: These are listed in Schedule-I of the DPCO, 2013, and are defined under section 2(1)(zb).
- Non-Scheduled Formulations: Defined under Para 2(1)(v) of DPCO, 2013, these include formulations not listed in Schedule-I.
Both categories are governed by DPCO, 2013, ensuring comprehensive price regulation.
Price Regulation Mechanisms
Scheduled Formulations:
- Annual Price Revision: The ceiling prices for scheduled medicines are revised annually based on the Wholesale Price Index (WPI) of all commodities for the preceding calendar year.
- Notification: The National Pharmaceutical Pricing Authority (NPPA) updates and notifies these prices on April 1st every year.
- Information Access: Details of the fixed prices are available on the NPPA website nppaindia.nic.in.
Non-Scheduled Formulations:
- Price Cap: For non-scheduled formulations, whether branded or generic, manufacturers are restricted from increasing the Maximum Retail Price (MRP) by more than 10% over the preceding 12 months as per Para 20 of DPCO, 2013.
Compliance with Good Manufacturing Practices (GMP)
Under the Drugs and Cosmetics Act, 1945, manufacturers are required to adhere to stringent Good Manufacturing Practices (GMP) outlined in Schedule M of the Drugs Rules, 1945. This compliance covers various aspects of drug production, including:
- Manufacturing
- Testing
- Labeling
- Packaging
- Storage
- Distribution
Licensing authorities are empowered to take action against any violations, ensuring that all processes meet the required standards.
Monitoring and Enforcement by NPPA
The NPPA plays a crucial role in monitoring drug prices:
- Scheduled and Non-Scheduled Medicines: NPPA keeps a vigilant eye on the prices of both categories to ensure compliance.
- Action Against Overpricing: If companies are found selling formulations at prices higher than permissible, NPPA takes strict action to recover the overcharged amount.
Financial Year 2023-24 Recovery
Highlighting the enforcement of these regulations, Smt. Anupriya Patel noted that during the financial year 2023-24, Rs. 72.73 crore was recovered from companies that defaulted on price regulations.
