Govt plans stricter quality control for medical kits

NEW DELHI: Manufacturers and importers of medical devices will soon have to face government''s quality control norms as mandatory pre-requisite for permit. The ministry of health has decided to soon bring the regulatory standards for this high-growth industry under the Drugs & Cosmetics Act. It will seek the technical support of the Bureau of Indian Standards (BIS) and notify as â€œsensitive itemsâ€� a large number of such devices/equipment/biological materials including in-vivo and in-vitro diagnostic kits. Medical devices market in India, with an estimated size of $1,250m at present, is growing at around 25% for the last few years. Although there are more than 120 domestic manufactures (including about 25 big) of these items, imports from countries like the US and Germany constitute roughly 50% of the market. There has been no regulation on either domestic or imported products so far in India, barring a set of optional specifications from the BIS for â€˜medical instrumentsâ€™, covering only a segment of this industry. Major producers of diagnostic kits and medical devices in India include Hindustan Syringes & Medical Devices, Hindustan Latex, Dr Reddyâ€™s Lab, Cadila Pharma, Lupin Laboratories, J Mitra & Co, XyCton, Bharat Biotech. â€œThe regulatory control will be effected by notifying more number of items under the Schedule C1 of the Drugs Act and concurrently bringing legislations on quality norms,â€� drugs controller general of India, Ashwini Kumar told the Economic Times . Institutions like BIS, Council of Scientific & Industrial Research, National Accreditation Board for Laboratories, AIIMS will assist the ministry. The health ministry is holding a workshop from September 17-20 in New Delhi on this subject, in which all state drug controllers, officials from BIS, CSIR and NABL as well as the manufacturers and the trade would participate, Kumar said. The aim is to lay down product-specific norms for manufacture, storage, distribution and sale of medical devices. Products that come under the description â€˜medical devicesâ€™ include items ranging from needles to artificial heart valves â€” such as hypo-dermal syringes, transfusion sets, intra-uterine devices, hearing aids, fever sponge products, bio-magnets, artificial teeth, in-vitro and in-vivo diagnostic products, respiratory devices, pharmaceutical ampoules and vials, X ray films. Earlier this year, the government had notified in-vitro diagnostic devices like HIV 1& 2, Hepatitis B surface antigen and Hepatitis C antibody in the Schedule C1 of the D&C Act. Besides, imported diagnostic kits were included in the import registration rules that are to be effective from January 1, â€™03. Schedule C lists sensitive biological products for healthcare and manufacture of all items listed therein are subject to specified conditions including licensing under the more exacting Form 28. While there is currently no regulation on imported medical devices in India, the fact that US-FDA allows exports of only products certified by itself or any of the â€˜Tier 1 countriesâ€™ (such as EU countries, Australia, Germany, New Zealand, Israel, South Africa) has introduced a certain level of quality discipline in the market, sources said.

Govt plans stricter quality control for medical kits

Manufacturers and importers of medical devices will soon have to face government's quality control norms as mandatory pre-requisite for permit.

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