The Tamilnadu Pharmaceutical Manufacturers Association (TNPMA) has plans to implement the strategy of 'Quality Circle System' to help the small-scale drug units in the state to modernize in accordance to the Schedule M norms.

Sources informed Pharmabiz.com that by this system, ten small scale units in a particular area or cluster would be united as a co-operative under the guidance of a WHO-GMP certified drug maker in that area. That firm would adopt, guide and help the units to make necessary modernization in accordance to the Schedule M norms. Seasoned professionals and quality control experts of the leader drug firm would visit the SSI units to conduct the feasibility study on modernization, and would direct them on the necessary machinery and required quality aspects. Further, the units would appoint a common consultant, thus helping to save on consultation fees. The units would try to purchase the necessary equipments in bulk, thus again saving a few lakhs of rupees by bargaining with the equipment suppliers.

Successfully being implemented by the small-scale drug manufacturers in Gujarat, the Quality Control System is mainly aimed to cut down the investment cost by at least by 30 percent, and spur the unwilling SSIs groping in the dark for want of direction and funds to go for modernization. As an example, the sources note that the Gujarat units had purchased HPLC machines for quality control worth over Rs.10 lakhs for 6.5 to 7 lakhs by purchasing in bulk, thus saving at least Rs.3.5 to 4 lakhs per unit. Similarly, their consultation charges were also reduced considerably by appointing common consultants. A high level delegation of TNPMA had recently visited the Gujarat units to study how far those units could successfully implement the system. The association has sent circular to its members explaining the system, and the response is very good, according to TNPMA sources.

"In Tamilnadu, most of the units are located in particular clusters like Alandur pharmaceutical zone, and it is practical to implement this system here. Orchid, a world standard drug manufacturer is located there, and they could help the surrounding units by acting as their leader in that area. Similarly, 15 WHO-GMP certified companies are there in Tamilnadu, and we have asked them to spare some time for the nearby units, and most have expressed their willingness to co-operate. Our members are not against implementing high quality standards. What we ask is only some more time and ways to reduce the investments" said T.S.Jaishankar, President of TNPMA.

Sources feel that each of the units are required to invest about Rs.10 to Rs.30 lakhs for modernization, and the Quality Circle System would help them save at least Rs.10 lakhs. There are about 300 SSI units in Tamilnadu, and about 60 percent have already modernized their manufacturing facilities conforming to Schedule M standards, claim TNPMA sources.