The Hindu : National : Notice issued to 1,372 manufacturing units

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Tuesday, May 02, 2006

National

National

Notice issued to 1,372 manufacturing units

Aarti Dhar

For non-compliance with good manufacturing practices

NEW DELHI: The Department of Ayurveda, Yoga, Unani, Siddha and Homoeopathy (AYUSH) has issued legal notices to 1,372 manufacturing units until January this year for non-compliance of good manufacturing practices (GMP) standards as notified by the Government in 2003.

In October 2005, the department had issued orders to State Secretaries under Section 33 (P) of the Drugs and Cosmetics Act to cancel licences of non-GMP complying units.

The first GMP manufacturing notification was issued in June 2000, giving two years for the existing units to ensure authentic and good quality raw material used in ayurveda, siddha and unani drugs and to ensure proper manufacturing process and quality control. Subsequently, a revised GMP was notified in 2003 with minor modifications and clarifications.

According to the department, which comes under the Union Health and Family Welfare Ministry, as many as 3,980 units manufacturing ayurveda, siddha and unani drugs had received the GMP certificate in 14 States. While 1,590 units continue to be non-GMP compliant, legal notices had been issued to 1,372 units as on January this year. These States are Andhra Pradesh, Gujarat, Uttar Pradesh, Orissa, Karnataka, Delhi, Rajasthan, Himachal Pradesh, Uttaranchal, Madhya Pradesh, Kerala, Maharashtra, Punjab and Haryana.

GMP standards

Non-compliance with GMP standards can lead to cancellation of drug manufacturing licence and a ban on the manufacture and sale in the open market. Government supply of these drugs would be stopped as GMP certification has been made mandatory for the Central and State Government purchase system.

The certificate is issued by the State Licensing Authority within three months of receiving application after proper inspection. It is valid for three years. The basic requirements for making a unit GMP compliant include minimum manufacturing space of 1,200 sq. ft. covered area plus 200 sq. ft. for the furnace section.

The manufacturing units should have space for receiving and storing raw material, manufacturing process areas, quality control section, finished goods store and rejected goods store.

The stress is on hygienic conditions, and good health of the workers who are required to undergo yearly medical check-ups, manufacturing records of all the steps, including sale and distribution have to be maintained and facility for quality control section can be provided in the premises of manufacturing unit, alternatively through a Government-approved testing laboratory.

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