New Delhi: Despite growing demands for laws mandating recall of drugs found ineffective or unsafe after reaching the market, latest norms by the Central Drugs Standard Control Organisation (CDSCO)—the country’s apex drug regulator—have been issued in the form of “guidelines”.
Guidelines on recall and rapid alert system for drugs (including biologics and vaccines) were released last month, over seven years after the issuance of the previous set of guidelines. But, except for reformatting of procedures and the documentation process, there are no changes in the new guidelines.
India, which takes pride in calling itself ‘pharmacy to the world’ has been on the backfoot over the last couple of years following multiple episodes involving Indian drugs, mainly cold and cough syrups, leading to serious adverse events including deaths in some countries.
These episodes have led to a collective call to ensure optimum quality of drugs manufactured in the country and to put in place strict deterrents and safeguards, including drug recall backed by force of law, to safeguard public health.
In the newly released guidelines, the CDSCO conceded that while there are references to product recalls, complaints and adverse reactions in a certain schedule in the Drugs and Cosmetics Act & Rules, there is at the same time a need for effective and uniform recall procedure, with timelines at every level of the supply chain.
At present, auditing and accountability are not in place.
The drug regulator said the new guidelines are “expected to be followed by all licensees—manufacturers, importers, exporters, stockists, distributors, retailers and the recall could be voluntary or statutory”.
The procedure may also be used by central or state drugs control authorities when urgent action is required to protect public or animal health.
According to the latest norms, “These guidelines would help in adopting to stepwise procedures to be followed in recall strategy and also help in recall evaluation at every level and achieve compliance within the time frame.”
The norms define recall as removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws.
But public health activists point out that unless a drug recall policy with legal backing—framed by the Union health ministry—is brought in, the guidelines will not serve any purpose.
“If, for example, there is a violation of these guidelines, what is the recourse available to the CDSCO? Nothing. That is my biggest concern with this,” Dinesh Thakur, a public health expert focused on improving health policy in the US and India, told ThePrint.
ThePrint reached Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi over call for comment. This report will be updated if and when a reply is received.
Main onus on company, distributors
Voluntary recall is a recall initiated by the licensee as a result of abnormal observation in any product quality during periodic review or investigation of a market complaint or any other failures.
Statutory recall, on the other hand, is a recall directed by drug control authorities after notifying that the product is considered to be in violation of the laws if government analysts declare that it is not of standard quality (NSQ).
But those advocating for stricter regulation of pharma products in the country stress that through the advisory, the regulator seems to be avoiding responsibility from the process of drug recall as the onus is on the manufacturer and the marketing company.
This may be particularly problematic for a country like India with a porous supply chain. The law should mandate that the regulator make publicly available on its database all recalls it makes, along with the class, reason, manufacturing name, and what was done with the recalled batch, experts say.
Thakur, a co-author of the book The Truth Pill: The Myth of Drug Regulation in India, told ThePrint that the current policy has way too many loopholes to fix accountability in cases of NSQ or unsafe drugs.
“Let’s assume a state drug authority, for instance the Tamil Nadu drug regulator, notifies the CDSCO that a batch of product made in Baddi, Himachal Pradesh, was found to be NSQ in its labs. How does this work? Which state drug regulator is responsible for publicly disclosing that they are affecting a recall? Does the guideline say this clearly? Who has the ultimate authority to verify that all batches of the product are recalled and accounted for, not just from Tamil Nadu but from the entire country?” Thakur asked.
“Is it the state drug regulator who identified the NSQ product? Who is responsible for informing the prescribers (doctors) that this particular drug/lot has been recalled? What about checking on local pharmacy stores that they have returned the product to the manufacturer in Baddi? Will a company have any interest in this where there is zero force of law behind this to take the product back and refund money to the local pharmacy in a country like ours?” he asked.
In 2022-23, as many as 3,053 drug samples—out of 96,713 samples tested—had been declared NSQ by the CDSCO, the Union health ministry informed the Lok Sabha earlier this month.
In response to another query in the Rajya Sabha on 6 August, the health ministry informed that during risk-based inspection of 400 drug manufacturing units in several states—authorities tested 812 drug samples, of which 118 (14.5 percent) were declared NSQ.
“No one knows which were these companies, what were the products and when they were recalled. Why is this information a state secret? Should the people of the country know if a medicinal product has been recalled under a law mandating this?” Thakur further asked.
Chinu Srinivasan, co-convener of New Delhi-based patient rights group All India Drug Action Network (AIDAN), too, said a good question to ask is what was the success of recalls under the previous guidelines. “There are no changes in the new advisory when compared to the previous one, even though the regulator seems to suggest that it means business this time round,” Srinivasan said.
(Edited by Radifah Kabir)
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