With the central Ayush department keeping mum on issuing protocols for clinical trials for Ayush products, the Commissionerate of Indian System of Medicines (ISM) in Tamil Nadu has chalked out a plan to draft a set of new guidelines for the same with the involvement of industry to solve the issues faced by the manufacturers of Indian medicines in the state, it is learnt.

The guidelines are mainly to solve the problem of long standing delay in issuing licences for fresh Ayush products and renewal of the old ones.

With this in view, the new Commissioner, Santhosh Babu, convened a meeting of officers of various departments and industry leaders last week and formed an 11-member committee to look into the matter. The committee comprises representatives from Tamil Nadu Ayurveda, Siddha, Unani Drug Manufacturers Association (TASUDMA), Pharmaceutical Manufacturers Association of Tamil Nadu (PMA) and Indian Drug Manufacturers Association (IDMA), TN branch. Each association will nominate two members each to the drafting committee, sources from the industry said.

Apart from industry side, five officials from various departments will represent the government in the committee. The state licensing authority for Indian systems, Dr S Kumar, will be the co-ordinator of the committee. It is learnt that the committee will submit its report to the Commissioner before April 22.

According to the manufacturers, the production and sale of proprietary medicines of Ayurveda and Siddha systems have come to a standstill in the state due to the halt in issuing licences for new products and renewal. The companies are operating only with the production of certain conventional medicines. According to them, the reason for not issuing fresh manufacturing licenses by the state authorities is due to the absence of protocols for clinical trials of traditional medicines which was made mandatory by the central Ayush department three years ago. To overcome the situation, the state commissioner has sought help of the industry and cooperation from all department officials, manufacturers attended the meeting told Pharmabiz.

The non-issuance of licences has forced several companies to stop production of several essential drugs and many hospitals and pharmacies are running short of important medicines including Nilavembu Kudineer, Mahavasnadi kwatha choornam and decoction powders. One year ago, when the hospitals were facing severe shortage of medicines, the Rajya Sabha member from Chennai, T K Rengarajan had also urged the health ministry of Tamil Nadu to take immediate steps to ensure adequate supplies of medicines to the Ayush hospitals across the state.

The industry people who met the Commissioner said till now the department of ISM was insisting that clinical trials were to be carried out for all new formulations as per central Ayush department norms. The clinical trials as envisaged by the Ayush department are highly expensive and not affordable to the small scale units of Tamil Nadu ISM industry.  But a change to this rule is imminent in Tamil Nadu on submission of guidelines by the newly formed draft committee. As per its suggestions, the state government will form separate protocols for the Ayush industry in Tamil Nadu, they said.

However, complaints are mounting from several quarters stating that the commissionarate has deliberately avoided NGOs and technical experts into the committee. One main demand is that the government should consider the involvement of NGOs working for promoting Siddha system in the state. The Chennai-based popular Siddha research centre, Centre for Traditional Medicines & Research (CTMR), was also not invited to the meeting.