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Indian GMP Requirements For Medical Devices Could Soon Resemble ISO 13485

India’s regulatory body, the Central Drugs Standard Control Organization (CDSCO), recently put forth a proposal to align the country’s good manufacturing practices (GMPs) for medical devices and in vitro diagnostics with the ISO 13485 quality management system standard. Manufacturers compliant with ISO 13485 may now find it easier to register their devices in India..

ISO 13485:2003 is an international quality standard specifically designed for medical device companies. Recently, India’s CDSCO drafted a proposal to align its GMP requirements with ISO 13485. CDSCO is currently soliciting comments on the proposed changes and is accepting comments through December 17, 2014. The proposed changes are focused on quality system requirements and, if enacted, will fall under the country’s Drug and Cosmetic Act.

If the changes are adopted, it may be easier for ISO 13485-compliant companies to enter the Indian market. Because the latest standard will intimately follow ISO 13485, manufacturers with quality systems that are already in line with the standard will have fewer regulatory hurdles when registering a new medical device in India. ISO 13485 is currently undergoing extensive revisions, and the updated version is projected to be released in 2015. ISO 13485 has not been updated in over a decade, however, and manufacturers should be prepared to adjust to changes that are certain to arise.

NPPA Issues Notices To Medical Devices

For monitoring of price movement of notified medical devices as drugs under DPCO, 2013, the National Pharmaceutical Pricing Authority has asked the manufacturers and importers of medical devices in the country to urgently produce a slew of documents to examine the extend of price variations of medical devices in the domestic market. The NPPA’s knee-jerk action in this regard comes in the wake of recent media reports that the prices of medical devices regulated as drugs under the Drugs and Cosmetics Act and Rules there under are sold at exorbitant prices with high profit or trade margins, particularly the prices of cardiac stents, drug eluting stents, orthopaedic implants, etc.

NPPA is of the view that because of over dependency on imported medical devices, prices of these products have gone up stupendously in past few years. Moreover, in the absence of price regulation, doctors, hospitals and retailers allegedly make money as commission for prescribing expensive stents or branded medicines. The idea is to bring such practices under scrutiny through the new policy.

The medical devices market in India was estimated at $6.3 billion in 2013 and growing annually at 10-12%. Most of it is dominated by imported products. According to a recent report by the Boston Consulting Group (BCG), around 70% of the medical devices used in India are imported. The NPPA has issued letters to all concerned manufacturers/importers including Abbott Healthcare, Boston Scientific India, Zimmer India, Edwards Life Sciences, Johnson & Johnson, India Medtronic Corporate, B Braun Medical India, 3M India, Harsoria Healthcare and Roche Products India.

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