In order to achieve uniformity in the compliance of Schedule T rules of the Drugs & Cosmetics Act, the Department of Ayush has issued a circular to the state drug licensing authorities providing a check list to help in the assessment of the Good Manufacturing Practices (GMP) being carried out by the industry.

The check list is dedicated for Ayurveda, Unani and Siddha drugs. Before issuing the GMP certification, the units should be inspected by the drug inspectors in accordance with the check list. The aim of the checklist is to achieve uniformity for GMP compliant units stated SK Chadda, director, department of Ayurveda, Unani, Siddha, Yoga and Homeopathy, Ministry of Health, Government of India.

In addition, the drug inspectors representing the State directorate will have to prepare a report on the GMP compliant unit and send it to the department of Ayush.

The check list of GMP for inspectors includes details of the management & supervision, training imparted to personnel, infrastructure of the plant which includes design of the facility, equipment and raw material handling aspects.

Under management and supervision, the ASU unit will have to provide details on the kind of supervision which is deployed to ensure smooth and efficient operation.

The drug inspectors will also have to ascertain if the managers and supervisors have enough knowledge of ASU medicines. Further, the licensing authority will also ascertain the hygiene principles and practices deployed to judge the potential risks.

Under the training programmes, the inspectors will need to see the awareness and responsibilities created by the management with regard to protecting ASU drugs from contaminants. The training will also need to focus on the nature of drugs in particular for its ability to sustain growth of pathogenic or spoilage micro organisms. Awareness about handling the ASU drugs is also ascertained.

Other aspects looked into are the environmental hygiene, handling storage and transport, cleaning, maintenance and personal hygiene.

In the area of infrastructure, inspectors will first need to see if the establishment is located far away form the polluted areas and if the location of equipment allows easy cleaning. The inspectors will also scrutinize structure of plant and if it is built of durable materials and the floors are constructed to allow adequate cleaning and drainage.

With regard to raw materials, clearance should be made at the reception centre with regard to rejection of the supplies if it contains parasites, undesirable micro organisms, pesticides or decomposed or extraneous substances. In the case of equipment, inspectors will also check if the instruments are calibrated regularly and are maintained and cleaned to prevent contamination.

There will also be scrutiny on the regular availability of potable water, design of drainage-waste disposal system to avoid contamination, pest control programmes practiced. In addition, inspections will also be made in the areas of packaging material, quality control, storage of finished products and record of written procedures for returned and salvaged drugs.

Adherence to pollution control norms and examination of the results of the previous self inspection and corrective measures taken during inspection are other notable aspects of the check list. According to JSD Pani, president, Karnataka Indian Medicine Manufacturers Association, the check list simplifies the process for the inspector and the industry and is a positive move from the Ayush department.