India Again Requests Trial Protocols from Combo Drug Manufacturers

The Drug Controller General of India asked manufacturers twice last year to submit Phase IV trial protocols— once in June and again in September — but most drugmakers have still not fulfilled the regulatory requirement.

The latest “regulatory reminder” from Controller General Dr. G.N. Singh did not specify whether drugmakers would face penalties for failing to submit the clinical trials protocol.

India is proposing several measures to improve the quality of drugs in the nation’s supply chain after the government released an estimate that 10 percent of drugs in production and distribution are substandard.