Dept of AYUSH calls for urgent quality compliance in ISM export sector
The Department of Ayurveda, Yoga & Naturopathy, Unani, Sidha and Homeopathy (AYUSH) is exploring ways and means for sensitizing the exporters of alternative medicines to follow strict GMP norms while manufacturing the products. The department will focus on promoting the production of quality alternative medicines and ensure that all the drug manufacturing units in the AYUSH segment, especially the ones catering to the export markets urgently comply with the GMP requirements.
The Health Ministry as per the provisions under the Drugs and Cosmetics Act has laid out the GMP norms (Schedule T) already.
In an informal interaction with Pharmabiz.com, Shekhar Dutt, the newly appointed secretary of Department of AYUSH stressed the urgent need for quality improvement in the alternative medicine manufacturing sector. Hinting that quality assurance would be the top priority area for the department in the coming days, Dutt said that the initial attempts would be made to ensure that the units manufacturing drugs meant for exports are following strict GMP norms.
The secretary informed that there has been significant progress in upgrading the status of testing laboratories after the announcement of GLP norms. He also felt that the legislation bringing in options for strict regulatory interventions in the sanctioning and the functioning of educational institutions in the AYUSH sector is also going to have a positive impact on the sector in the near future.
The Centre had recently announced its plans to supply medicines from AYUSH sectors to the government healthcare institutions after sourcing it through its centralized purchase system. The move had proved to be an indirect incentive for SMEs in AYUSH sector to comply with GMP norms as the purchase was supposed to be carried out only from companies possessing GMP certified facilities. Though the GMP for ISM sector was in place for more than a year now, the compliance is restricted to the big and medium players in the industry. The department's plans to focus on the quality aspects of the industry should be seen as an attempt to help AYUSH sector tide over the challenges of future.
An Exim Bank sponsored study had recently identified seven tracks of ISM products viz., human medicines, veterinary medicines, nutraceuticals, cosmeceuticals, agriculture related products, dietary and health supplements and healthcare services, and has classified the target markets into four zones. It had suggested a phased approach with the aim of eventually exporting the entire Indian systems of medicine as a comprehensive package. According to the study, the various steps involved in successful marketing of ISM products in the international marketplace include planning for exports, selection of products, selection of markets, customer analysis, analysing distribution channels, product promotion strategies, pricing strategies, competitor assessment, strategies for integrated branding and measuring customer satisfaction.