New Delhi: India could soon have a strict national statutory drug recall system in place, ThePrint has learnt. This would be used to remove from the the market medicines that
state or central drug regulators have declared to be of substandard quality.
The provision has been introduced in the revised Drugs, Medical Devices, Cosmetics Bill, 2023, which the health ministry is set to send for the Union cabinet’s approval before it is tabled in Parliament during the ongoing monsoon session, according to government sources.
The bill, a copy of which is with ThePrint, is set to replace the existing Drugs and Cosmetics Act, 1940.
It proposes that when a drug, cosmetic or medical device does not conform to the standards of strength, quality or purity, performance or any other parameter specified in the bill and rules framed under it, the licensee would have to recall and withdraw the rest of the batch.
The provision would also apply to drugs, medical devices and cosmetics used in traditional methods of treatment such as ayurveda, homeopathy and unani among others, according to the bill.
Drug recall is the process of removing or correcting a marketed drug that violates the laws and regulations governing safety, efficacy, or quality. A recall is typically issued when a product is found to be defective, contaminated, mislabelled, or to potentially pose a risk to the health and safety of patients.
The provision for recall was not in the draft bill released for public feedback last year.
The existing Drugs and Cosmetics Act and rules do not have a separate clause on drug recall, even though product recalls are mentioned in a few places in Schedule M of the law.
What’s missing is an effective and uniform recall procedure, with timelines at every level of the supply chain. There is also no system of auditing and accountability, as was mentioned in guidelines issued on the subject by the Central Drugs Standard Control Organisation (CDSCO) — India’s central drug regulatory agency — in 2017.
In practice, this means that by law there is no provision to withdraw an entire batch of drugs deemed to be potentially substandard, and at most state drug regulators can order a withdrawal of a particular batch from their state. Given that India is a common market, however, it is possible that the same batch is then dispersed across multiple states, say pharmaceutical analysts ThePrint spoke to.
“One major flaw in our country’s drug regulation is the lack of a law to recall medicines found to be NSQ (not of standard quality); it is like identifying a murderer but not punishing him for the proven crime,” pharmaceutical expert Chandra M. Gulhati told ThePrint.
Both central and state-level drug authorities pick up thousands of samples from retail outlets for the purpose of determining their quality, said Gulhati, yet except for listing the concerned brands and batches on their websites and issuing notices to manufacturers, no action is taken to pull the products off the market.
“It is ridiculous and exposes consumers to avoidable risk,” he said. “I recall, some years ago, we had identified an antipsychotic brand of a multinational company that had just about 50 percent of the active ingredient. Yet it was not recalled from across the country.”
Other experts pointed out that the new provision, while welcome, needed details on implementation to be effective.
ThePrint reached Drugs Controller General of India Rajeev Singh Raghuvanshi, who heads the CDSCO, for comment via telephone, but had not received a response when this report was published. The article will be updated once a response is received.
Lacunae accepted by drug regulator too
The CDSCO has previously conceded that there is a major gap in the existing framework.
In 2017, the regulatory agency issued guidelines on a recall and rapid alert system for drugs (including biologicals and vaccines), where it said that “in the Drugs & Cosmetics Act & Rules, there are references for product recalls, complaint and adverse reactions in Para 27 & 28 of Schedule M and also conditions of license for defective product recall in Rule 74(j) and Rule 78(i), but effective and uniform recall procedure, with timelines at every level of supply chain is required and at present auditing and accountability is not in place”.
The guidelines added: “This has been observed in instances where drugs [are] declared as not of standard quality by government analysts, incidents where serious adverse effects or death have been reported, in case of banned drugs under section 26 A, defects where voluntarily the manufacturer withdraws drugs from the market etc.”
Issuing the guidelines, the CDSCO had said that it expected licensees (manufacturers, importers, stockists, distributors, retailers) to follow them and that the recall could be voluntary or statutory.
“The procedure may also be used by drug control authorities of the Centre or state when urgent action is required to protect public or animal health,” it said.
In reality though, said a senior CDSCO official, the implementation has been a problem.
“This is also because these guidelines are not backed by law,” the official added.
Devil in the details
Speaking on condition of anonymity, a public health activist told ThePrint that while the provision related to drug recall in the latest bill is a welcome addition, it doesn’t enter into details and all it does is define what is covered under the proposal.
“Unless rules are framed with explicit scope, responsibilities and penalties, this may mean nothing,” said the activist. He added: “All I see here is a high-level definition of what a recall is and under what conditions a drug should be recalled.”
Another pharmaceutical expert, Chinu Srinivisan, who is associated with the All India Drug Action Network — an independent network of several non-governmental organisations working to increase access and improve the rational use of essential medicines — also feels that the rules under the proposed law need to be specific in order to be effective.
“For example, if you had to withdraw a crore of tablets of a particular batch somewhere, six months after it entered into the trade, how would you do it? How will you ensure honesty in the manufacturer and trader nexus,” he asked. “The rules have to pave a way to answer these questions.”
(Edited by Poulomi Banerjee)