India’s Pricing Authority Proposes Label Addition for Essential Drugs

India’s drug pricing authority is proposing a requirement to display special markings and ceiling prices on labels for life-saving and essential drugs to curb overcharging for the drugs.

The National Pharmaceutical Pricing Authority (NPPA) said its labeling proposal is intended to improve consumer awareness on the use of these medicines, and improve accountability and self-regulation of pricing across the industry. The proposal was made after discussions with the Ministry of Consumer Affairs.

One of the biggest challenges NPPA faces is in monitoring compliance of retail ceiling prices of scheduled drugs by manufacturers, importers, marketers, distributors and retailers, the agency said. The challenge is compounded by the fact that more than 600 formulations, totaling 6,000 separate brands, are sold across India.

NPPA said it randomly samples products to detect cases of overcharging, but is unable to deal with the magnitude of the problem. NPPA has filed thousands of overcharging cases against manufacturers, with most still pending in litigation.

The labeling proposal would affect only scheduled drugs under the Drugs Prices Control Order (DPCO) of 2013. Labels would contain a distinguishing mark, such as a red strip, with the words “DPCO Scheduled Drug” printed in black ink. The label also would include the ceiling price per unit.

One India pharma consulting group says NPPA should have consulted with the country’s Central Drugs Standard Control Organization before making the proposal. The agency needs to ensure labelling changes are in compliance with regulatory requirements and do not impact the quality of the products, said TwoFour Insight Group. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.