The government is striving to bring the Rs 8,000-crore Ayurveda drug industry and traditional medicine system under a quality certification system, a move that could help the domestic industry in tapping the export potential, mainly in the emerging economies. The department of Ayush has launched a quality control system in which Ayurvedic drug manufacturing companies would need to get their products validated by third party certifiers authorised by the autonomous body Quality Council of India (QCI), mainly on the parametres of purity levels and good manufacturing practices. While the scheme is voluntary initially, it could become mandatory in future.
?This would help sieve the grain from the chaff in the Ayurveda industry which has over 9,000 producers in the country, and could help us immensely to capture markets in Africa, Latin America, South East Asia among other geographies,? said Ranjit Puranik, CEO of Mumbai-based Shree Dhootapapeshwar Ltd and general secretary, Ayurveda Drug Manufacturer Association.
The countries in these regions usually insist on recognised quality stamps, as most of them don?t have regulatory system of their own unlike matured markets like the US and UK. Puranik also added that in the long-run the investment on quality control per unit might come down if this becomes the passport of mutual recognition between countries. Currently, the domestic exporter incurs cost on lab tests in every batch of drugs to check conformity to GMP standards and purity. The same tests are then repeated by the clients in the importing country to check on the quality aspect, resulting in duplicity of efforts and added costs.
?We have formulated two levels of standards for Ayurvedic drugs. A seal of ?Ayush standard mark? on a product would imply that it complies to all quality related domestic regulatory requirements prescribed under the Schedule T of the Drug and Cosmetics Act. If the product carries an ?Ayush premium mark?, it signifies conformity to manufacturing standards as laid out by WHO for international trade,? said Giridhar Gyani, secretary general, QCI.
Srihari Kotela, the director of Hyderabad-based FoodCert India, one of the two certifiers authorised by QCI till now to carry out the scheme told FE the cost of certification would depend on the number of products and number of employees of an organisation among other factors. ?An organization, which has 20 employees and produces one product, would roughly need to invest about Rs 30,000-35,000 for the Ayush standard mark and around Rs 45,000 for the Ayush premium mark,? Kotela said.
There are two schools of thoughts prevailing within health ministry on the future of the scheme. An arm of ministry foresees the scheme becoming mandatory and merging with the existing regulatory framework in times to come. However, another set of officials are skeptical, as it would mean having to amend law to make the seal a statutory requirement. However, even the latter concede that such a mark would gain in principle acceptance among state drug regulators, which regulate manufacturing, sale and distribution of drugs. Puranik adds that the mark would eventually become mandatory through market forces, even if law doesn?t mandate it.