India: Medical Device and Investment Policy Reforms

The Indian government has released a list of policy initiatives planned for 2015. Among other measures, India plans to:

  • Amend and upgrade the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 (discussed further below)
  • Continue developing an online system for submitting clinical trial applications
  • Release a revised National List of Essential Medicines
  • Finalize clinical trial accreditation standards

In early January 2015, India‚Äôs Ministry of Health and Family Welfare released for comment a draft Drugs and Cosmetics (Amendments) Bill, 2015 — amending the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The Ministry plans to introduce the bill into Parliament in the February-March 2015 session.

The revised bill includes a definition of medical devices that covers in vitro diagnostic (IVD) products, as well as expanded requirements for manufacturing, importing and marketing medical devices. The revision provides more detailed rules for medical device clinical trials, including rules for compensation in the event of clinical trial death or injury. A new centralized advisory board would be created to consult state and central government agencies on administrative and technical matters.

Looking to replace the Schedule M-III, the Central Drugs Standards Control Organization (CDSCO) released other draft rules in December 2014 that bring India more in line with international quality management standards. The draft regulations detail good manufacturing practices and requirements for equipment and production facilities for medical devices, IVDs and reagents.

Also in December 2014, the Indian government allowed 100% foreign direct investment (FDI) in the medical device sector. This move could trigger Western companies to invest in medical device manufacturing facilities in India.