Quality Circle for small drug firms opened in Ahmedabad

The Gujarat state branch of the Indian Drug Manufacturers' Association has launched the Ahmedabad branch of Quality Circle on Saturday.

Under the concept, small-scale pharmaceutical units become members of a group even while safeguarding their individual identities, with the immediate aim of adhering to revised Schedule-M guidelines of the Drugs and Cosmetics Act.

The long-term goals include purchasing raw materials and machinery together. Eight small-scale pharmaceutical units located in the Vatva GIDC industrial area of Ahmedabad have come together to form a Quality Circle.

S P Adeshara, commissioner, Food and Drugs Control Administration (FDCA), who conceptualised Quality Circle and asked IDMA to implement it, formally inaugurated the Quality Circle in Ahmedabad on Saturday.

Speaking at the function, Adeshara said, "There was apprehension among the SSI units on meeting the revised Schedule M guidelines. I believe the concept of Quality Circle will clear their apprehensions."

Eight small-scale pharmaceutical units, all with a turnover of less than Rs two crore, have already agreed to become members of the Quality Circle.

"We will increase the membership of a QC up to about 15 or 20. There will be more such QCs in Ahmedabad and other districts in the near future," said Quality Circle co-ordinator Neeraj Kumar Singh.

IDMA Gujarat state branch chairman Kamlesh Udani has held several rounds of discussions with the FDCA and industries to promote the concept.

Schedule M guidelines of the Drugs and Cosmetics Act require pharmaceutical companies to invest a minimum of Rs 40 to 50 lakh in upgrading their air control and handling systems, quality control systems, water system.

The pharma units which have a World Health Organisation Good Manufacturing Practices certification automatically conform to the revised Schedule M guidelines, but the smaller companies need to invest a huge amount before December 31, 2004, to meet the requirements.

"This is where the role of QC will come in. Each member will be required to spend just Rs 2,000 for technical evaluation and another Rs 2,000 for financial evaluation and reports. Then, if we purchase the equipment in bulk, the cost of the machinery is reduced by well over half," Singh said.

The first Quality Circle, a co-operative of small scale pharmaceutical industries, was launched about six months ago with five member-units.

Singh said six of these companies have already filed applications with the FDCA for meeting schedule M guidelines.

"Forty per cent of these companies have already submitted plans to FDCA for adhering to revised schedule M guidelines, and the overall success rate in working together as a unit is over 70 per cent," Singh said.

The QC at Mehsana was the first-ever co-operative in the pharmaceutical sector anywhere in the country.