PRESS RELEASE

Wellquest becomes the first Indian CRO to receive 
Statement of GCP Compliance from UK-MHRA

Mumbai 23 August 2004: Wellquest, the independent clinical research division of Nicholas Piramal India Limited (NPIL), becomes the first Indian CRO (Clinical Research Organisation) to receive the Statement of GCP (Good Clinical Practices) Compliance from the UK-MHRA (Medicines & Healthcare Products Regulatory Agency), for clinical studies carried out to support the registration of generic products in the international regulated markets. 

While marketing authorization has been given to Pharma companies in the past based on studies carried out at Wellquest, the GCP Compliance Statement comes on the heels of a strict facility inspection of Wellquest conducted by the UK agency, one of the most stringent drug regulatory authorities, a few months back. This is reflective of the high quality and ethical standards of Wellquest as a CRO. Speaking of the feat, Dr. Satish C Bhatia, President Wellquest, said, “This approval is certainly a big feather in our cap and a testament to our commitment towards compliance to the highest global standards and will encourage more international clinical research projects to be outsourced to India”.

India is fast emerging as an important destination for clinical research activities and Wellquest is an early mover amongst the professional CROs in the country. Besides the UK-MHRA, Wellquest has also obtained approval from the Brazilian regulatory body ANVISA and several international pharma companies based on facility audits.

Speaking about the achievement, Dr. Swati Piramal, Director Strategic Alliances & Communications at NPIL, said, “We are poised for rapid growth with such compliance recognition. This will augur well for Wellquest to provide its quality services in clinical research to the international pharmaceutical industry.”

About Wellquest
Established in 2000 by NPIL as an independent division, Wellquest’s state-of-the-art facilities occupy 20,000 sq ft of space over four floors of the Wellspring Hospital in Mumbai. The infrastructure consists of a spacious 60-bed ward, 6-bed ICU, pharmacy, phlebotomy stations, archives, sophisticated bioanalytical laboratory replete with LC/MS/MS machines, and a NABL-accredited central path-lab. Wellquest’s quality systems are geared towards compliance with GCP/GLP guidelines of FDA, ICH and WHO and it has successfully carried out several clinical research projects for submission to UK, Europe, South Africa, Australia, North America and Latin America. Its services include evaluation of generic and NDDS products and Phase I-III clinical trials with NCEs (New Chemical Entities), herbal and biotech products. Several leading national and international Pharma companies are currently on its list of clients.

For further information please contact

Vijay Sathye
Vice President, Investor Relations and M&A
Nicholas Piramal India Ltd.
Tel: 9122 - 56637899
Mobile:  9324689774
E-mail: vsathye@nicholaspiramal.co.in