India: New Medical Devices Regulation Bill and Foreign Facility Inspections

Reintroduction of Medical Devices Regulation Bill (MDRB)

In 2006, the MDRB was proposed by the Ministry of Science and Technology to consolidate laws related to medical devices and to establish the Medical Device Regulatory Authority of India (MDRA). This proposal was aimed at establishing and maintaining a national system of controls for the quality, registration, manufacturing, safety, performance, and availability of medical devices in India.

The MDRB was intended to be fully implemented by December 31, 2009 as a Parliament Act, but it did not pass India’s Council of States and was subsequently abolished. Recently, there has been talk of the MDRB being reintroduced in 2011, with many industry players expecting it to be passed in the Indian Parliament during the summer 2011.

If enacted in 2011, the MDRB will govern all medical devices throughout India and will establish the MDRA as the regulatory and enforcement body for medical devices. All medical devices in India will be required to abide by provisions for the design, manufacture, packaging, labeling, importation, sale, use, and disposal of medical devices as specified in the MDRB. The MDRA is expected to be headquartered in New Delhi (with 4 regional offices) and the top officials of the MDRA will likely be appointed by the central government. In addition, if the MDRB is enacted, one or more Medical Device Safety Appellate Tribunals (MDSA) will be established to hear appeals made by medical device companies about decisions of the MDRA.

Central Drugs Standard Control Organization (CDSCO) to audit & inspect foreign manufacturing facilities

A long-awaited practice, the CDSCO has finally begun its pilot inspections of manufacturing facilities in foreign countries in order to ensure the quality of imported drugs and medical devices into India. In May 2011, a three member team of CDSCO officials (two assistant drugs controllers and one director of the Regional Drugs Testing Laboratory) conducted their first-ever inspection of six companies in China.

Ultimately, the team was only able to inspect five facilities in China on their two-week visit. Chongqing Daxin Pharmaceutical Company, an exporter of bulk drugs to India, refused inspection, prompting CDSCO officials to ban this Chinese company from selling to India.

In addition, the CDSCO plans to audit and inspect several manufacturing facilities in Italy in the near future. Once the Italy pilot project is successful, the CDSCO will introduce the audit and inspection of manufacturing in other countries as well.