NEW DELHI: In the biggest overhaul of the Drugs (Prices Control) Order (DPCO), 2013 in years, Centre has significantly narrowed drugmakers’ liability in overcharging cases, while introducing a host of long-pending changes sought by the pharma industry. The amendments, notified on June 30 and effective immediately, ease compliance for pharma companies, simplify pricing approvals for certain new drug launches, strengthen record-keeping requirements and clarify overcharging rules, sources told TOI.”These provisions are in line with govt’s objective of improving ease of doing business while preserving the integrity of the drug price control framework,” Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance, told TOI.The biggest change comes under paragraph 24, which provides that if a manufacturer can demonstrate compliance with the prescribed disclosure requirements and adequately disseminated the revised price, overcharging will be calculated only on the stock handled by the retailer, distributor or stockist found selling above the notified ceiling price, rather than on the entire batch. Under the previous framework, companies faced recovery demands running into crores of rupees and multiple legal battles, even where the overcharging would be a fraction of stock sold. Further, another amendment provides that “any other existing manufacturer launching the same new drug within twelve months of retail price fixation of such new drug… shall not be required to apply”, eliminating the need for a separate price approval. Such manufacturers will instead be required to intimate the launch through a prescribed form, within one month, reducing procedural delays and streamlining the process.Further, govt can now notify different ceiling or retail prices for the same scheduled drug based on therapeutic rationale, pack size, packaging, dosage compliance or dosage form, instead of applying a uniform price across all presentations.
