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Operators of Ayush-approved laboratories in Chennai have alleged that several Indian Systems of Medicine (ISM) drug manufacturers in Tamil Nadu are supplying pharmaceuticals to central and state hospitals, private healthcare centres, and Ayush pharmacies without conducting vital quality analysis and shelf-life stability tests.
According to these operators, mandatory protocols requiring products to undergo testing in Ayush-approved facilities are being widely bypassed. This breakdown in the compliance mechanism has raised serious apprehensions regarding the quality and therapeutic efficacy of alternative medicines circulating within public and private healthcare supply chains.
The core of the issue lies in the severe shortage of specialized testing infrastructure compounded by regulatory bottlenecks. Dr MS Ramaswami, director of an NABL accredited Ayush-approved laboratory in south Chennai, said that while the state hosts over 500 ISM drug manufacturers, there are only 15 Ayush-approved laboratories in Tamil Nadu. Compounding the deficit, the government-run laboratories located at Arumpakkom and Tambaram rarely accept samples from private companies, restricting their operations primarily to testing samples submitted directly by the drug control department or the state manufacturing unit, TAMPCOL.
According to Dr Ramaswami, it is legally and procedurally mandatory for manufacturers to submit detailed quality compliance and stability test reports to institutional buyers along with their supplies, especially for government tenders. Previously, a rigorous mechanism was in place where manufacturers routinely verified their batches through the handful of approved private and co-operative facilities, such as the four private labs in Chennai and the Impcops co-operative society unit near Adyar, before distribution. However, he alleged that a major systemic lapse has emerged over the last five years, as institutional procurement officers have largely stopped verifying these essential laboratory certificates during the receipt of medical stocks.
The laboratory operators further pointed out that the digitisation of licensing has inadvertently created a loophole in quality enforcement. While the transition to the government's e-Aushadhi portal has successfully brought transparency to the initial application process, it has altered how manufacturers source their data. Dr. Ramaswami alleged that because major cities host numerous non-specialized laboratories, manufacturing companies find it easy to secure generic quality certificates to upload with their online applications. These certificates, however, do not originate from Ayush-approved laboratories authorized to evaluate specialized ISM formulations.
Countering these sharp allegations, the state ISM drug controller, Dr YR Maneksha, maintained that the regulatory framework remains robust and defensive of consumer health. Speaking to Pharmabiz, Dr. Maneksha clarified that when any manufacturer applies for a product licence, they are strictly required to submit comprehensive laboratory test reports alongside their application. These technical dossiers are subsequently evaluated and vetted by a government-constituted expert committee before any marketing authorization or licence is approved.
The drug controller also emphasized that the regulatory framework relies heavily on internal quality protocols, saying that each licensed manufacturing company is equipped with an in-house laboratory for day-to-day testing. Further, regulatory officers actively draw random samples directly from commercial pharmacies and marketplaces, routing them to government facilities to check for standard quality compliance.
As the tender processes move forward, the industry calls for stricter enforcement of physical document verification at the time of delivery to bridge the alleged gap between portal approval and public distribution.
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