India: New Draft Guidelines on Approval of Clinical Trials and New Drugs

In July 2011, the Central Drugs Standards Control Organization (CDSCO) has issued new draft guidelines on the approval of new drugs and clinical trials. Before a drug is approved in India, the product must demonstrate safety and efficacy. The Drugs and Cosmetics Act currently governs the approval of clinical trials and the import or manufacture of new drugs for marketing. However, the requirements for both clinical trials and new drug approvals can vary depending on the nature of drug. Thus, the new guidelines stipulate general requirements for the approval of both clinical trials and new drugs in an effort to streamline the application and approval process.

New drugs, as defined by the Drugs and Cosmetics Act, include unapproved drugs, modified or new claims, mainly new dosage forms, new indications, etc. To obtain permission to import, manufacture, or market a new drug, submission of Form 44 (application for permission to import or manufacture a new drug/to undertake clinical trial) along with prescribed fees and all relevant data to the CDSCO is required. A new drug will continue to be considered new until 4 years after its approval date, or until its inclusion in the Indian Pharmacopoeia – whichever is earlier.

Clinical trials are required to be conducted in India starting from Phase I for new drug substances originated in India. For new drug substances from another country, Phase I data is required along with the new drug application. Permission will then be granted to either repeat Phase I trials or to conduct Phase II trials. Phase III trials are required to be conducted in India before permission to market the drug is given.

Indian government officials believe that these new guidelines will help the CDSCO to better review each drug application and ease the preparation of electronic submissions.

The CDSCO has asked stakeholders to send in comments by August 24, 2011 before finalizing the guidelines.