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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) |
