New Delhi: With the Narendra Modi government making it compulsory for cough syrup manufacturers to get samples of the product tested before export, it is now being questioned by pharmaceutical analysts why the same mandatory evaluation process should not be followed for all drugs being sent out of India.
This arises from concerns that sample testing of cough syrups alone may not address the problem of alleged loopholes in the drug quality management system in the country, ThePrint has learnt.
The Union government had Monday notified an order making it compulsory for cough syrup makers to get samples of the products tested before exporting.
Starting 1 June, these companies will have to get a certificate of analysis from specified government laboratories (labs) before exporting the drugs. The notification follows reports of two back-to-back instances of some made-in-India cough syrups being linked to deaths of children in Gambia and Uzbekistan last year.
The additional layer of quality check is being particularly put in place for cough syrups as in both cases it was this class of drugs that was found, or alleged, to have been contaminated with glycol and ethylene glycol, a toxic substance that can sometimes be fatal, especially for children, sources in the Union health ministry told ThePrint.
While in the Gambia episode, the Indian government gave a clean chit to Maiden Pharmaceutical, the company involved, saying that no contamination was found in the batches exported, in the second case, the manufacturing license of Uttar Pradesh-based Marion Biotech was canceled after its samples failed the quality tests.
Now, the notification by the Director General of Foreign Trade, stipulates that cough syrups would be permitted to be exported from India “subject to the export sample being tested”.
The government stipulation on pre-export sample checking of cough syrups has, however, led pharma analysts to raise concerns of it being “not practical” and “superficial” owing to “limited government resources”. Industry insiders too spoke of private laboratories too being allowed to conduct the tests, to reduce pressure on government facilities.
ThePrint reached Union health secretary Rajesh Bhushan on email for comments, but receives no response till the time of publication of this article. This report will be updated as and when a response is received.
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‘Positive move, but not enough’
“The decision to ensure the quality of cough syrups that are exported from India is good and much required,” said pharma analyst Salil Kallianpur. “Quality control for all drugs — not just cough syrups — is necessary. Currently the onus, and rightly so, is on the company to ensure that the quality is not compromised.”
The reason why low-quality medicines are released is because for smaller operators maintaining a high-quality standard is expensive and they seal business deals at relatively low prices, forcing them to cut corners, said Kallianpur, adding, therefore quality is the easiest to compromise on.
According to the pharma analyst, quality is maintained in the private sector through regular inspections by drug inspectors and other officers of the Central Drugs Standard Control Organisation, wherein lies the other problem.
“With severely limited capacity the state finds it difficult to inspect and ensure quality standards at every single manufacturing unit in India,” he alleged. “This means a lot of medicines that are released into the market and are consumed are not of optimal quality”.
The severity of the limitations of state capacity can be gauged by the fact that while there are several recalls by drug companies of their products in overseas markets, one rarely hears of any such thing happening in India, Kallianpur added.
‘Clean the house, first’
According to Malini Aisola, co-convener of the All India Drug Action Network (AIDAN), a not-for-profit orgamisation that works for patients’ rights’, the government order was a “move to counter the bad PR” the government is getting following last year’s deaths and “to provide some reassurance to the international community, to be viewed as taking some action”.
“It is obviously superficial and doesn’t get to the root of weak regulation in the country which also leaves gaps for rogue manufacturers to capitalise on the global market. I would call it a strategic and limited political intervention,” she claimed.
Aisola added: “In my opinion, the sustainable solution lies in cleaning houses on regulation in India. I don’t think, however, that it is realistic, or necessarily justified, to demand India exert itself the same way for every batch that leaves its shores and may be complying to the regulatory requirements of other jurisdictions.”
She also raised the issue of the government not having made public the Y.K. Gupta committee report so far, pointing at the alleged lack of transparency in the system. The committee was formed in the aftermath of cough syrups manufactured by Maiden Pharmaceuticals, a Sonipat-based company, being linked to the Gamibia incident.
The health ministry, in March this year, had announced that manufacturing licenses of 18 companies had been canceled, while show cause notices to more than 70 other firms had been issued, after they were found violating good manufacturing practices. The government however never revealed the names of these companies.
Chinu Srinivasan, a pharmaceutical expert associated with not-for-profit pharmaceutical firm Low Cost Standard Therapeutics (LOCOST) and AIDAN, too, said that batch testing of all drugs or cough syrups leaving India may not be practical.
“What can be done is random batch testing instead and I see the current move as a PR exercise that may peter out soon as it will put too much burden on the government laboratories,” he said. “What needs to be done is to have a well thought out plan in place so that drugmakers comply better with the existing provisions of drug safety.”
Drugmakers meanwhile, raised other objections to the government notification.
Viranchi Shah, president, Indian Drug Manufacturer’s Association, the largest network of small and medium drug firms in India pointed out that most countries have mechanisms in place to test the quality of drugs arriving at their shores.
“Also we feel that designating only government labs for Certificate of Analysis will delay the export process and therefore some private labs should also be allowed to carry out this process,” he told ThePrint.
(Edited by Poulomi Banerjee)
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