Manufacturing rules notified for ASU drugs

By Our Special Correspondent

NEW DELHI, JUNE 30. The Government has notified the Good Manufacturing Practices (GMP) Rules for Ayurveda, Siddha and Unani (ASU) medicines to standardise the quality of ASU drugs manufactured in about 9,000 pharmacies in the country and gain credibility in the export market.

This was announced by the Secretary (Indian Systems of Medicine and Homeopathy) in the Ministry of Health and Family Welfare, Ms.Shailaja Chandra, at a press briefing here today.

The GMP Rules for ASU drugs indicating the essential infrastructure, manpower and other requirements came into force on June 23, 2000. The existing manufacturing units, however, have been given a buffer period of two years to improve their infrastructure and other stipulated requirements.

While all qualifying units would be issued a GMP certificate with immediate effect, the registered vaidyas, hakims and sidhas and other teaching institutions which prepare and disburse medicines within their own network of patients based on earned credibility have been exempted from the purview of the GMP, Ms.Chandra said.

The Secretary said the GMP now would work as a benchmark for foreign Governments to test ASU products. The British Government had expressed a keen desire for such standardisation of quality rules, given the potential market Ayurvedic and unani products hold.

``Now that we have set standards to judge, the country will confidently move towards better quality medicine in ISM (Indian System of Medicines) and also the level of quality, reliability and safety would be maintained while renewing licences every two years,'' she said in response to a question on guaranteeing GMP's success.

The licensing authority for ASU drugs in most States such as Maharashtra, Himachal Pradesh, Haryana and Uttar Pradesh was the Drug Controller, while in places such as Delhi, it was still the Department of ISM.

Asked why vaidyas were kept out of GMP rules, Ms.Chandra said, it would be difficult to police the large numbers of vaidyas who generally practice with their reputation at stake. ``But as and when complaint about any adulterated medicine comes to us, we get the sample tested in our central assessment laboratory. This monitoring should be done by the State Governments and we are working on a scheme to strengthen the State assessment laboratories,'' the secretary said.

She was confident that the GMP Rules were achievable both by the big manufacturing units - about 25 in the country - and the small sector units as well and there would not be any stiff resistance from the industry.

Under the GMP Rules, specifications have been laid down for location and surroundings of the building which houses the manufacturing unit, water supply, sewage disposal, waste container, cleaning, storage of raw materials, packing materials, finished goods store, working space and sanitation, health, clothing and hygiene of workers.

According to the notification, the GMP Rules will also ensure that raw materials used in the manufacture of drugs are authentic, of prescribed quality and free from contamination. Provision for quality control, proper labelling of products and maintenance of records have also been made mandatory under the GMP Rules.

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