Sunday, September 11 2005 14:18 Hrs (IST) - World Time -

New Delhi: India is set to tighten norms for manufacture and export of ayurvedic products, following countries like Britain and Canada restricting imports of such products citing presence of heavy metals in them.

The move would help Indian pharmaceutical companies make deeper roots in the European markets and increase acceptance for their products internationally, a report from the Centre for Monitoring Indian Economy (CMIE) said.

Developed countries such as Canada and the United Kingdom have recently imposed restrictions on the imports of ayurvedic products saying that the products cause some side effects.

Pharma majors from India, at present, were entering through inorganic route especially to diversify the risk faced in the US generic market, it said.

Once the norms are introduced, big players in the sector such as Dabur, Himalaya Drugs, Zhandu Pharma, Baidyanath and Charak will have to undergo heavy metal testing, product standardisation procedures and stringent clinical trials for their ayurvedic products.

Secretary of Ayurvedic Drug Manufacturers Association Narendra Bhatt, however, said: "The heavy metal content is part of Ayurvedic pharmacopeia and toxicology studies conducted by manufacturers have yielded negative results."

At the same time, the government was also working towards making the rules less complicated and help the sector grow both in the national and international market, it said.

The cabinet has already approved the decision to withdraw the requirement for industrial licensing on both drugs and pharmaceuticals items. Industrial licensing was generally felt to be duplication of procedure, the CMIE report said.

The Good Manufacturing Practices that became effective from July one, 2005 have already been amended. The Government, however, wanted to further amend the Drugs and Cosmetic Rules in order to make Good Laboratory Practices (GLP) mandatory for all drug-testing laboratories in the country, it said.

The mandatory GLP compliant labs were a measure towards increased acceptance of Indian drugs by the global regulatory authorities, it said.

The Government is also considering setting up a vaccine manufacturers council, an apex body to promote vaccine manufacture and exports.

The proposed council would aim at upgradation of regulations and technology from vaccine manufacture to reach global standards besides providing financial assistance to such projects, the report said.