Updates on India’s Medical Regulations

The CDSCO has recently published on their website the “National List of Drug Manufacturers / Loan Licensee and Certificate of Pharmaceutical Product (COPP) Holders,” the “National List of Approved Testing Laboratories,” and the “Capacity of Testing Laboratories under the CDSCO.”

The first document outlines the number of original licensees, number of loan licensees, and the number of COPP holders. This information covers each of the 29 Indian states and 5 union territories. Additionally, the document provides information on the manufacturing sites and the COPP holders themselves. The document details the name of the manufacturing site, the address, the manufacturing license number, validity period, and the categories of products that are permitted. This CDSCO update serves as a very useful resource since companies can now see that drug manufacturing is most robust in the western parts of India (e.g. the states of Gujarat and Maharashtra).

The National List of Approved Testing Laboratories lists the names, addresses, and contact information of all approved testing laboratories. The list is divided by the different states of India. The Capacity of Testing Laboratories under the CDSCO lists the total testing capacity of all labs in India.

The Drug Controller General of India (DCGI) has also proposed to the Health Ministry to establish advisory drug panels to determine the “desirability” of new drugs and vaccines before new drug and biotech approvals, and clinical trial approvals. These committees will be made up of pharmacologists and specialists that can provide expert opinion on issues related to how essential certain drugs are to the Indian market.