Medical Devices Bill : Before Parliament Soon

The draft Bill seeking to introduce a regulatory system for medical devices used in clinical applications will be introduced in the parliament soon. The Bill with certain key provisions, was discussed by the Drug Technical Advisory Board and is forwarded by the DCC subcommittee.

The Bill is learnt to have included standards and approval procedures for more than 1000 products available in the healthcare market.

The Bill is expected to be part of the Drugs & Cosmetic Act by including a specific definition for "medical devices". It has also proposed a separate  Medical Device Division in the office of Central Drug Standard Control Organization (CDSCO) and the setting up of appropriate regulatory mechanism for certification, quality assurance and post marketing surveillance of imported as well as locally made medical devices.

Broadly, the products included in the draft Bill are electronic as well as mechanical devices made of plastic and metals, which are used within the body and externally for medical and therapeutic applications. Though there are standards set by the Bureau of Indian Standards (BIS) for almost all theses products to ensure the manufacturing quality, the sources close to the technical committee, confirmed that since these devices are used in the clinical applications, the safety and therapeutic accuracy have to be tested and approved exclusively as it is followed in case of drugs.

"A lot of other factors have also to be considered and incorporated in the regulatory framework as the engineering (mechanical, electronic) and other scientific aspects are also to be looked after before evaluating the safety and manufacturing standards for these devices to be granted license for manufacturing and marketing," the official said.

Currently, there are no regulations for the manufacture, imports and marketing of these products in the country. The proposed regulatory framework will put all the medical devices including hearing, aids, patches, straps, electronic massaging devices, inhalers, etc used for healing under regulatory mechanism. And none of these products are currently under regulatory monitoring for certification, quality assurance and post marketing surveillance. Also, many of these devices are sterilized using various techniques, efficiency of which need to be validated. In view of the emerging regulatory code for medical devices, the CDSCO has already initiated measures to build up capacities to have a separate division to deal with the new area, it is learnt.

(Ref : CHRONICLE PHARMABIZ Dated January 20, 2005).

Pharma Packaging : Bilcare's Expansion plan for Exports

Fitch Ratings India has assigned an 'A-(ind)' rating to Bilcare's Rs. 400-m long-term debt programme. The rating outlook is stable. The rating reflects the company's established position in the blister-packaging segment in the country, research and development (R&D) capabilities and a track record of steady growth in revenues and net cash accruals over the past few years. The company's business model is based on providing integrated solutions to its clients; from advising on the right packaging material for a particular drug to importing, processing and printing the material for the client, rather than just supplying the ordered material.

Bilcare is a leading player in the domestic solid pharmaceutical packaging market. It provides comprehensive packaging solutions to the pharmaceutical sector. The company's manufacturing facility is near Pune (Maharashtra). During H1 '05, it recorded revenues of Rs 724m with a net income of Rs 120m.

Bilcare has state of the art manufacturing  and R&D facilities at Shiroli near Pune. In this facility the manufacturing of packaging solutions is done in a totally dust-proof and temperature and humidity controlled atmosphere conforming to cGMP norms. Being the first pharma packaging company to comply with cGMP norms in the country, Bilcare now manufactures multilayered laminates for pharmaceutical packaging, featuring exclusive entries for personel and material through a dedicated air lock system having circulatory air shower systems fitted with 1 5-micron filter abrasion resistant seamless epoxy coated flooring and a high efficiency exhaust system. "Microbial count in the area is zero and area particle count is less than 40,000 particles of below 0.5 microns. Bilcare also has an advanced coating facility, the only one of its kind in Asia," says Praful Naik, president, Bilcare.

According to Naik, all processes in the facility are completely validated and encompass critical quality checks at each stage. "Quality materials inputs procured from the world's leading manufacturers, complying to stringent USFDA/ EU/ Japanese & ISO 9002 requirements, coupled with the validated process, excellent systems and infrastructure ensure world-class products that meet all regulatory and quality requirements globally," he informed.

Adding that the concepts of specific quality and drug stable pharma packaging are yet to be fully emerged among the Indian pharmaceutical industry, Naik said that Bilcare blister films were the most cost effective and novelly designed pharmaceutical packaging systems excelling international quality standards.

(Ref : Economic Times Dated January 4, 2005)