Indian pharmaceutical companies aiming drug discovery programmes and new chemical entity (NCE) business in the EU markets may have to adopt good laboratory practices (GLP) certification soon to export their drugs to the region. The contract research organizations (CRO) that are looking for assignments from these countries would also be asked to go for GLP certification.

Foreseeing the consequences of the proposed EU legislation, namely REACH (Registration, Evaluation and Authorisation of Chemicals), the Central Government has intensified efforts to achieve a Mutual Acceptance Data (MAD) status with the Organisation for Economic Cooperation and Development (OECD) for the GLP certification given by India's National GLP Compliance Monitoring Authority.

Even though the National GLP Monitoring Authority is currently following OECD principles for GLP certification, India is only a provisional member of the OECD for GLP. Its status as an Observer to the OECD's Working Group on GLP and as a member of the OECD Test Guidelines Programme doesn't allow MAD status. With most of the developed countries recognizing OECD guidelines on GLP, Central Government hopes to facilitate export-oriented growth in drugs, pharmaceuticals and contract research by achieving MAD status. Once OECD accepts Indian certification, domestic industries can have their test facility (products) certified from safety angle by Indian GLP Authority and submit its report to all other countries, R Saha, Head, National GLP Compliance Monitoring Programme, informed pharmabiz.com.

According to Saha, the number of companies showing interest in getting GLP certification from Indian GLP authority is on the rise. "Five companies have already received our certification. Orchid Chemicals and Pharmaceuticals, Chennai was the most recent company that has Indian GLP certification," he said. Orchid has GLP certification in areas like physical - chemical testing, safety pharmacology and pharmacokinetic studies, toxicity studies, mutagenicity studies and analytical and clinical chemistry testing. The other companies that have already sensed the importance of GLP certification are Dr Reddy's Laboratories (Discovery Research Division), International Institute of Biotechnology and Toxicology, Gharda Chemicals Limited and Jai Research Foundation. Two of these companies are CROs. There are 13 applications currently before the Authority, Saha informed.

GLP certification in India is currently voluntary in nature. The National GLP Programme functions through an Apex Body, which has secretaries of concerned ministries/departments, Director-General, CSIR and the Drugs Controller General of India as its members with secretary-DST as its chairman. This Apex Body is responsible to ensure that the National GLP Programme functions as per OECD norms and principles. The Apex Body is supported by Technical Committee on GLP, National Coordination Committee for OECD Test Guidelines Programme and Legislation Committee to enact a national legislation on GLP. The legislation committee is seeking various options to make more companies comply with GLP norms.

The Authority also has the mandate to train GLP inspectors. As on date, there are 33 trained GLP inspectors. The Authority is planning to train another set of inspectors in September 2005.

The Authority is also conducting awareness programmes in all parts of the country. It has tied up with Confederation of Indian Industry and would organise three regional awareness workshops on GLP in the coming months, Saha said.

With regard to the procedure involved, Saha said that the test facilities/laboratories have to apply in the prescribed application form. "After the application for GLP certification is received, a pre-inspection of the laboratory is carried out by the GLP inspectors, followed by a final inspection. The report, prepared by the inspection team, is put to the Technical Committee for recommendation to Chairman, National GLP Compliance Monitoring Authority. GLP Certification is valid for a period of three years and the GLP Secretariat organizes annual surveillance and a re-assessment during third year for maintaining the certification," he explained.