Though GMP norms under Schedule T of the Drugs and Cosmetics Act for ISM sector is in place for the last three years in the country, the compliance rate by Ayurvedic units remains dismal at less than 20 per cent, as the state enforcement agencies are clueless on many of its mandates. With no direction coming from the Department of Ayush, neither the industry nor the drug controllers are in a position to take a clear stand on implementation.
Although it seems ironical that the lawmaker has to be educated on law, various state drug control agencies are of the opinion that the Department of Ayush is almost completely unaware of the technicalities of the standardization norms. Hence, no central directive has so far reached the regional enforcement bodies to proceed further on the rules.
It may be recalled that the official deadline for the standardization in the Ayurveda, Siddha, Unani and Homeopathy sectors is already over after several extensions. However, neither the industry nor the department is clear about the status of the GMP compliance.
Interestingly, the Secretary, Dept. of AYUSH, Shekhar Dutt, when asked about the GMP implementation, said that he is not fully aware of Schedule T and so as the enforcement part of it.
According to industry sources the Department heads coming from quite unrelated portfolios often seem either reluctant to learn the sector fast or incompetent to understand the requirements of the industry properly.
Nevertheless, the new Secretary has crossed the limits of ignorance with his barefaced response on the much-talked-about quality manufacturing norms in his very own sector. "Although the country talks big about the export potential of Ayurveda and herbal products, the decision makers who are responsible for guiding the industry to that goal still grope in the dark," said an industry source.
Though the GMP norms, which are mandatory, have been in effect since 2001, the compliance is still limited to only big and medium players. The large chunk of SSIs and tiny units remain un-upgraded. This absolutely shows that the voluntary initiatives by the large units only help adopting GMP standards in the sector.
"The department's focus on the quality aspects of the industry should be seen as an attempt to help AYUSH sector tide over the challenges of future. But, unless the department is equipped with competent brains to deliver the direction, the country can never exploit the global opportunities even for this traditional sector," quipped another source from the industry.
The Union Health ministry had recently announced its plans to supply medicines from AYUSH sectors to the government healthcare institutions as the purchase is supposed to be carried out only from companies possessing GMP certified facilities as an indirect incentive for SMEs in AYUSH sector to comply with GMP norms. However, the responding to a query in this regard, the Secretary said "the information is not yet reached us."
The secretary is also unaware of the various studies and projections on the potential of ISM products especially Ayurveda an herbals done by institutions like Exim Bank.
An Exim Bank sponsored study had recently identified seven tracks of ISM products viz., human medicines, veterinary medicines, nutraceuticals, cosmaceuticals, agriculture related products, dietary and health supplements and healthcare services, and has classified the target markets into four zones, It had also suggested a phased approach with the aim of eventually exporting the entire Indian systems of medicine as a comprehensive package.