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DCGI Discontinues WHO-GMP Certification

The Drugs Control Society of India (DCGI) has taken a decision to discontinue issuance of WHO-GMP certificate for both pharma products and plant audits. The decision comes in the wake of objection raised by the World Health Organization on handing over these certificates at random.

The WHO-GMP had been a mandatory requirement for global markets entry and specifically for countries which had no dedicated regulatory authority. It was also required for specific drugs which were being used for supplies under the global disease control initiatives such as TB, HIV, Malaria control project funded by WHO and other international agencies. These certificates were issued for products and later to plants where these products were manufactured and audited by WHO.

The Indian Pharma drug regulator has been issuing the Certificate of Pharmaceutical Products (COPP) which is on par with the WHO-GMP certificates.

For the marketing of drugs within the country only Schedule M certification is required.

The COPP certificates have a validity period of two years and there will be a joint inspection carried out by both Central Drugs Standard Control Organization (CDSCO) and the state drugs control departments, Dr. BR Jagashetty, Karnataka drugs controller, told Pharmabiz.

(Ref: The Chronicle Pharmabiz dated February 12, 2009)

HCL Technologies To Offer Tech Services To Medical Device Cos

Eying the huge growth potential of Life Sciences and Healthcare Sectors and the resultant growing need for advanced medical devices, India’s leading IT service provider HCL Technologies Ltd. will offer advanced technology services to the medical devices companies for exploring the emerging markets with low cost products.

With its state-of-the-art technology solutions, HCL focuses on the emerging markets, particularly in the BRIC countries (Brazil, Russia, India and China) where medical device and equipment markets are currently valued at US $10 billion, said Shivakumar Krishnamurthy, GM, Engineering and R&D services, HCL.

He said in order to understand the issues and other challenges faced by medical devices companies among numerous opportunities in the emerging markets, HCL has conducted a Global Medical Devices Industry Study in collaboration with IIT, Kharagpur and Doctor Kares Hospital, New Delhi. The study with over 283 respondents highlighted the top requirements of launching medical devices in the emerging markets.

The company’s medical device development services, including concept, design, manufacturing, certification and support help medical device manufacturers shorten the product development lifecycle and introduce new products to the market faster Shivakumar explained.

“HCL was the first Indian service provider to be certified for ISO 13485:2003 for the design and development of medical devices, and currently it has engagement with 19 of the top 40 medical devices companies in the world. The medical devices customers feel the need to enter these markets or fortify their existing positions in these markets. However, the increasing R&D costs and need of low cost indigenous devices is hampering their growth. The need for innovation and global R&D network has encouraged us to highlight our offerings on medical device practice,” the R&D chief of HCL said.

R. Balamurugan, practice director (Medical) while demonstrating the testing lab facilities said HCL is the only Indian services company to offer genuine full lifecycle R&D services, which includes market research, concept development, design engineering, testing and compliance, and after-sale services. HCL’s testing labs are the first private labs in India which provide end-to-end independent testing services to its clients.

He said since all products have to adhere to global regulations, the company has invested heavily in the test labs and is providing end-to-end independent testing services to customers to help them launch a fully tested and verified product in the market in a minimum possible timeframe.

(Ref: The Chronicle Pharmabiz dated February 12, 2009)

Other News

Commerce Ministry Extends DEPB Scheme Withdraws Reduction In DEPB Rates
Nirmed Invests Rs 3 Cr For Greenfield Project To Manufacture Wound Care Products
DuPont Opens Integrated Knowledge Center In India
Marck To Set Up Sterile Dosages Facility With Rs 800 Mn
GE Healthcare To Invest $50-60 Mn In India In 3 Years





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