More than 600 ISM manufacturing units in Tamil Nadu have no GMP Certification as yet according to the new State Licensing Authority (SLA) for Indian System of Medicine. Only 52 companies including big and small, out of a total of 682, have the licenses and only they are eligible to export their products to foreign countries.
Dr Sarojini Devi, the head of SLA, said six applications for GMP certification are pending with her office, and after inspection by the officials they would be cleared.
The SLA said that financial constraints of the units may be the main reason that is holding them back from applying for the quality assurance certification. For establishing the required facilities, a unit has to spend more than Rs 35 lakh which most of the companies cannot afford now. She said a majority of units having no GMP facilities are located in Kanyakumari district and they are all SSIs. But for marketing their products within the country, the certification is not required, but cannot to export.
When contacted Dr Vijay A Mehta, secretary of the Tamil Nadu Ayurveda, Siddha, Unani Drug Manufacturers Association (TASUDMA) said the units are facing problems as the department is passive in initiating welfare measures to the industry. All the units are running the business with the support from the banks. If they have GMP certification, to an extent, all the units can run the show in a better way. "Even if we apply for something, the papers are pending with the office of the department," he said.
Dr T Thirunarayanan, secretary of Centre for Traditional Medicines and Research (CTMR), who is the Advisor to TASUDMA, said most of the units are tiny in scale and are operating from small huts with little finances.
"Without the department's co-operation no unit can grow in their business. The department has to support these units for their development. Here they are only interested in regulating and controlling. Even the 52 companies, having GMP Certification, are also lacking facilities," he said. He added that in the year 2002, the government had helped the industry with financial support, but it was only for a few years.
Dr Sarojini Devi said manufacturing of ISM drugs is regulated in the Drugs & Cosmetics Rules, 1945 under Schedule T, which has been enforced from 23rd June, 2000. The implementation of GMP ensures total quality assurance covering all the spheres in a manufacturing system. The components of GMP provisions under Schedule T includes, inter alia, infrastructural requirements, working space, storage area, equipment, health & hygiene, documentation and quality control.