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The Centre’s recent alert on “not of standard” quality (NSQ) drugs has reinforced the call for stringent action against spurious drug makers, and greater transparency on follow-up action, say experts.
In its latest NSQ alert (for August), the Central Drugs Standard Control Organisation (CDSCO) listed over 50 medicine samples, including those used to treat diabetes, blood pressure, certain antibiotics and calcium supplements, to name a few.
This has left consumers unsettled on their daily dose of medicine, and the absence of information on action taken by companies and the Centre, following these alerts, has added to their safety concerns.
Large drugmakers featured on the list including Sun Pharma, Alkem and Glenmark, have distanced themselves from the NSQ samples, calling them counterfeits or “spurius”.
The Centre too sought to allay consumer fears, saying NSQs “are not generally life threatening”, and risks were negligible. A Government official clarified, that samples were picked up from State warehouses and distributor warehouses, before it entered the market.And entire batches of NSQ products were discarded.
Outlining anti-counterfeiting measures, companies said they’d adopted 3D security strips, QR codes, unique product identifiers and difficult-to-replicate packaging, to stay ahead of counterfeiters that sold medicines with similar sounding names.
Sudarshan Jain with the Indian Pharmaceutical Alliance (IPA), called on consumers to buy from authorized retailers, on a prescription and with a bill (so it is traceable if something is amiss), and to check QR codes. (IPA is a platform for large domestic drugmakers.)
Spurious alarm
The “spurious” label, though, brings in an element of “criminality” - where the medicine may not have the drug’s active ingredient or may have minimal quantities of it – making it ineffective in treating fever in children, or diabetes or blood pressure, in adults, experts point out.
“The Centre should take stringent action on those making spurious drugs, it is a crime,” says Jain, concerned on the impact these incidents are having on the industry.
Former Director General with the Pharmaceuticals Export Promotion Council of India, R Udaya Bhaskar, puts the responsibility on manufacturers to track and recall substandard drugs.
And, since health is a State subject, there should be better coordination between Central and State drug regulators, so a suspicious product flagged in one state is communicated and acted upon by others, he says.
Regulatory expert Dr Chandra Gulati pointed to the mismatch between 10,000 manufacturing units and regulatory officers to inspect them; and the competition between States involving more manufacturing plants - as the core problem, leading to products slipping between the regulatory cracks.
Industry-insiders point to regulators like the US Food and Drug Administration that put information in public domain, including the transgression by companies and follow-up action, till it is resolved. Pointing to the international cough syrup issue, where deaths of children were linked to products from India, an industry-watcher said, action taken by the companies and the regulator need to be publicly available to instil confidence in consumers.
More central action
Government officials said, the CDSCO is in discussion with State regulators to up the drive against NSQs and bring it below 4 percent, (from 15 percent, severalyears ago). In February 2017, the Union Health Ministry cited the national drug survey and said, “the percentage of NSQ Drugs in India has been found to be 3.16 per cent and that of Spurious drugs 0.0245per cent.”
The Centre has also been undertaking risk-based inspections at manufacturing sites and mandated QR codes on large brands, to keep track of the supply chain.
This August, Union Health Minister JP Nadda said in Parliament, that Central and State drug authorities conducted risk-based inspections across 400 premises/ firms - identified on their risk criteria, including number of drugs declared NSQ, complaints, criticality of the products etc.
Subsequently, 300-plus actions including issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses etc, have been taken by State authorities in line with the Drugs Rules 1945.
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