Very few drug units in Tamil Nadu have implemented GMP at their manufacturing facilities so far, despite warning and pressure from the Tamil Nadu drug control administration. The drug controller's office had alerted that the licences of firms that have not conformed to the new norms will not get renewed.
According to reliable sources, only 20-odd SSI units out of a total 750 to 800 in the state have gone for modernizing their manufacturing facilities in the recent past as per the estimation by Mashelkar committee. However, industry circles claim about sixty per cent of the drug making units in the state have advanced manufacturing facilities matching Schedule M norms, including 15-odd firms having WHO-GMP manufacturing facilities with world standards.
Sources said the move of Tamil Nadu Pharmaceutical Manufacturers Association (TNPMA) to introduce Quality Circle System to help the small-scale drug units in the state to modernize in accordance with the Schedule M norms have not elicited much response from its members.
As per the plans, the idea was to form ten small-scale units in a particular area or cluster as a co-operative under the guidance of a WHO-GMP certified drug maker in that area. That firm will adopt, guide and help the units to make necessary modernization in accordance with Schedule M norms. Seasoned professionals and quality control experts of the leading drug firms have to visit the SSI units to conduct the feasibility study on modernization, and will direct them on the necessary machinery and required quality aspects. Further, the units will appoint a common consultant, thus helping to save on consultation fees. The co-operative will try to purchase the necessary equipment in bulk, thus again saving a few lakhs of rupees by bargaining with the equipment suppliers.
"We will definitely pursue the matter with our members after the Indian Pharmaceutical Congress (IPC), Chennai, as now we are busy organizing the event. It is not that we are against adopting global manufacturing standards and the parameters suggested by the Government. The rules are to better the industry and it is our duty to follow it. Nevertheless, practically it is not possible for the industry to adapt within the short time frame. We have been demanding an extension upto year 2007, and it is welcome if we get another two year extension," says T S Jaishankar, Chairman, Confederation of Indian Pharmaceutical Industries (CIPI) and President of TNPMA.
At least half of the units in the state, especially those outside the Chennai city, will have to down their shutters for ever if the Government fails to extend the deadline, says B Sethuraman, Hon. Secretary of TNPMA. "It requires at least Rs. 10 lakh to set up the infrastructure, but the banks and other financial institutions insist on collateral security, despite RBI and Government of India directions to provide loans without collateral security to pharma units up to Rs.25 lakh. In the present conditions, the entrepreneurs are also worried whether to invest or not as returns are not assured immediately," notes Sethuraman.
At the same time, the industry leaders admit that the units are a bit slow in their response to the government directive. "I agree with the fact that a bit of lethargy and relief has been crept into the minds of entrepreneurs of many units, following reports appeared in Pharmabiz and some other newspapers that Schedule M deadline may be extended for two years. Nevertheless, it should not be interpreted as our unwillingness to comply with the rules. It shows our helplessness," says Jaishankar.
Meanwhile, the drug control administration in Tamil Nadu has not given manufacturing or renewal licences in the last six months to any drug manufacturing unit in the state that have not complied with the Schedule M norms, except to some units on emergency grounds like exports or similar top priority requirement that mandates a valid licence.
According to A Somnath, the Drug Controller (in charge), Tamil Nadu, this was as part of the strategy to strictly ensure all units in the state obey the rules on upgrading the facilities in accordance to the deadline on 31st of December 2003.
"We have sent individual notices to all the registered units in the state numbering 750 to 800 on the consequences for not obeying the deadline. The notice clearly stated violation would attract cancellation of manufacturing licence as per rules after 1st January 2004. Extension to present deadline is different, and so far, we have not been informed of the extension. It is our job to ensure the rules are being implemented,'' says the Drug Controller.