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A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 9th Year of Publication

Cover Story

Government plans stricter quality control for medical devices

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 "sensitive items" 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 $2,250m at present, is growing at around 25% for the last few years. Although there are more than 120 domestic manufacturers (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 medical instruments, 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. Reddy’s Lab, Cadila Pharma, Lupin Laboratories, J Mitra & Co, XyCton, Bharat Biotech. "The 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," drugs controller general of India told.

[Ref: The Economic Times – 18/9/02]


ABSTRACT OF THE DISCUSSIONS HELD DURING THE WORKSHOP ON  GOOD MANUFACTURING PRACTICES & INSPECTION OF MEDICAL DEVICES  ORGANISED BY  
THE CENTRAL DRUGS STANDARD CONTROL ORGANISATION
 New Delhi * September 19, 2002
TOPICS
COVERAGE
Introduction to Medical Devices Definition; Classification; Critical, not-critical devices; Distinction from drugs and their role in therapy; General Characteristics; Global & National Market position; Category-wise commercial growth, Standards of medical devices
Status of Medical Device

Manufacturing in India

Scenario of manufacture of medical devices in different States; Type of devices produced; facilities provided; adoption of GMP’s; availability of manpower, machine, raw materials, methods; Problems faced in terms of acceptance of regulation, upgrading knowledge through Associations & availability of reference materials
International Regulation scenario Background, regulatory agencies; Distinction from Drugs; Nature of regulation; certification; Hormonisation; pricing; import & export
Quality Control, GMP of IOL Introduction to IOL, Types of IOL, Manufacturing in India and Internationally, Classification, Manufacturing facility requirement, Type of control expected, Quality Control.
Current National Regulation Status on Medical Devices Background, status of regulatory provisions covering medical devices; comparison between GMP’s for drugs and medical devices. Regulatory role of Central and State licensing Authorities, Limitations, inclusion of more devices under the Drugs & Cosmetics Act and its impact on existing Industry; import and prices of medical devices
Medical Device Packaging Packaging Materials, their specifications and validation both for sterile and non-sterile; testing; International standards on Packaging; Customer needs; Availability of packing materials in India.
Medical Device Evaluation Evaluation objective, Types of testing e.g. physical, mechanical, chemical & biological specification; Testing of Raw Materials, In-process controls and final evaluation; sampling plans, Types of samples, testing laboratories; Present status of testing facilities in Govt. & Private Sector, requirement of testing laboratories, creation of Appellate laboratory.
Group Discussion Case presentations, Limitations at their levels, Experience of participants, views and comments; aspects that needs coverage on subsequent day; specific suggestions for coverage in Medical Device Regulation and Schedule M III revision.
Medical Device Sterilization Objective; Medical Device Sterilization needs; Sterilization Methods; Effect of various methods on material & product; Shelf life; Cost comparison; sterilization facilities in India; Sterility Assurance.
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