Daily Intelligence for Industry Leaders

India's Delhi Anti-Corruption Branch (ACB) reports have alleged ₹600 crore procurement scam involving the directorate general of health services (DGHS) and the central procurement agency (CPA). The scam includes claims of changing tender rules, using fake companies, and raising prices for medical supplies. Items like X-ray machines, bedsheets, and ORS sachets were bought at much higher prices than usual. Three officials have been arrested, and the investigation continues to uncover more information. 

The Department of Pharmaceuticals has amended the Drugs (Prices Control) Order, 2013 to introduce Form IA for intimating new drug launches. The amendment simplifies the launch process for existing manufacturers by replacing the requirement for fresh retail price approval with a post-launch intimation within one month.

The Department of Pharmaceuticals has clarified the framework governing overcharging liability under the Drugs (Prices Control) Order, 2013. Manufacturers demonstrating compliance with prescribed price communication requirements will have their liability restricted to the quantity of stock actually overcharged by distributors or retailers, providing greater regulatory certainty.

The Food Safety and Standards Authority of India (FSSAI) has issued notices to six beverage manufacturers over the use of the term "energy drink" and related misbranding and misleading claims. The regulator observed that there is currently no notified standard for products classified as "energy drinks" under the Food Safety and Standards framework, and objected to promotional claims suggesting functional or therapeutic benefits, such as boosting energy or enhancing focus. The action reinforces FSSAI's ongoing efforts to ensure compliance with food labelling and advertising regulations and to prevent misleading claims that may deceive consumers. 

The Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945, expanding their scope to expressly cover cell or stem cell-derived products, gene therapeutic products, and xenografts alongside recombinant DNA (r-DNA) derived drugs. The amendments take effect from the date of publication in the Official Gazette. 

India's Central Drugs Standard Control Organisation (CDSCO) is undertaking a nationwide reconciliation exercise to identify and authenticate missing drug approvals from 1945, including legacy products approved by State Licensing Authorities (SLA) before 1988. Manufacturers will be required to submit historical approval records to help create a comprehensive national repository, address gaps in the CDSCO approval database, improve regulatory oversight, and verify that older formulations comply with current safety and efficacy standards. 

The Department of Pharmaceuticals has amended the Drugs (Prices Control) Order, 2013 to permit separate ceiling or retail prices for therapeutically justified variants of the same drug. The amendment recognizes differences in packaging, pack size, dosage compliance, and dosage form while determining regulated prices.

The Department of Pharmaceuticals has strengthened record-keeping requirements under the Drugs (Prices Control) Order, 2013. Manufacturers must maintain records relating to APIs, bulk drugs, formulations, and other prescribed information for at least seven financial years, with records retained until the conclusion of any pending proceedings, if any.