Thinking logically, the Government has provided a major relief to alternate traditional drug manufacturers. The Government has done away with the “illogical” mandatory requirement of submission of analytical test reports, involving huge cost implications, at the time of submission of tenders or rate contract applications for the public procurement of Ayurvedic, Siddha, Unani and Homoeopathic (ASU&H) medicines. It has subsequently direct the Central and State agencies not to seek these reports from the bidders.
In a circular issued recently to all the Government agencies, the Union Ayush Ministry said that “requirement of analytical test report of ASU&H medicine at the time of submission of tender or rate contract application does not seem logical owing to huge cost implications to Micro, Small and Medium enterprises for testing of all those medicines which may not qualify or get shortlisted for the rate contract.”
Rather, it maintained that manufacturers should be asked to submit the test report or Certificate of Analysis only for the batch or lot of medicines actually delivered by them to dispensaries or hospitals under the rate contract.
The AYUSH Ministry’s move followed complaints from the sector that State and Central ASU&H drug Government agencies were putting in condition in the tender document seeking analytical reports from the accredited labs. In the past few years, as the demand for the alternate drugs has increased in view of side-effects of the allopathic medicine, there has been growing stress on the safety of herbal medicine too. The World Health Organisation (WHO) has framed a set of guidelines to address the issue and promote the efficacy and quality of traditional drugs.
Welcoming the Ministry’s decision, Nishant Jain of B Jain Pharmaceuticals said that it will help industry at large as getting testing done at time of submission of tender proves very costly for SME/MSME. Hence, submitting COA at time of supply looks like a favorable decision when seen from one perspective, he said.
Jain, however, cautioned that lowest quote should not be the main criterion for selection.
According to him, there should be certain basic parameters for any company to be able to supply to the Government. “Besides lowest quote, parameters like GMP certificates, third party quality audits, export capability, and sample COA of any fixed number of products should be implemented to ensure drug quality,” he added.