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New guidelines being planned for streamlining recall of medicines

At present, there is little clarity on how effectively regulators are able to remove such products from the market after they are found to have quality issues.

Written by Prabha Raghavan | New Delhi |
October 7, 2019 4:09:40 am
While India already has guidelines to recall medicines found not to be meeting quality standards, they have so far been used “mainly for biologics,” said a senior Health Ministry official on condition of anonymity.

The government is planning to draft new guidelines to ensure its drug regulators can effectively recall substandard medicines released in the market here — in a move expected to improve the quality of drugs consumed by patients in the country.

At present, there is little clarity on how effectively regulators are able to remove such products from the market after they are found to have quality issues.

While India already has guidelines to recall medicines found not to be meeting quality standards, they have so far been used “mainly for biologics,” said a senior Health Ministry official on condition of anonymity.

The fresh guidelines are expected to be the first in India for medicines made from chemical ingredients, the official added. “When a batch is found to be NSQ, it has to be immediately recalled from the market, but there is no proper mechanism right now to give this information to the chemist shops,” the person said.

Following recommendations of a sub-committee set up to look into the issue, the Drugs Consultative Committee (DCC) in its last meeting decided to formulate these rules.

“Further, to protect the public from potential use of Not of Standard Quality (NSQ) drugs after its declaration, the committee recommended that CDSCO shall immediately publish such data/reports on its website for which the state and central drug control authorities shall inform such cases of NSQ to the CDSCO … immediately after such declaration by the government analysts,” state minutes of the meeting held on August 20. The CDSCO, or Central Drugs Standard Control Organisation, is India’s central and top drug regulatory body.

The DCC has also decided to ensure that state and central laboratories “immediately” inform the concerned drug control authorities of the NSQ drugs declared. “Further during the discussion in continuation to this point, it was also recommended to update the status of action taken (upto its logical conclusion as per Drugs and Cosmetics Act and Rules) by the respective authorities on Not of Standard Quality drugs specially those identified under the National Drug Survey programme,” it added. The Indian Express has viewed a copy of the minutes. The sub-committee that examined the matter had recommended measures to strengthen the country’s drug recall system in a phased manner.

In the short term, an “immediately achievable goal” was to ensure “uniform implementation” of recall guidelines by the Centre and state. This could be done through means like appointing nodal officers in each region and constituting a “special committee” at the central level, according to the committee’s suggestions. In the medium and long-term, the committee recommended measures such as developing a mobile application and an online portal to connect “all stakeholders”.

India’s drug regulations state that pharmaceutical firms manufacturing drugs found to be substandard are supposed to withdraw from sales of “all issues already made from that batch/unit.” The CDSCO had, in 2017, also published guidelines on recalls and a “rapid alert system” for NSQ medicines in the country. However, enforcement at present has been ineffective, according to experts.

In some instances, by the time the information reaches the shop floors, the batch is “already consumed” by patients, the official cited above said. “There are rules already available, but the issue is that we don’t have a regulatory framework to enforce them,” said Dinesh Thakur, a public health activist known as the whistleblower who highlighted data manipulation issues at Ranbaxy, once India’s top drug maker.

“How do you know how much stock is available in the market? Because health is a state subject, CDSCO doesn’t have a count on any of this,” he said. “Even if you can account for all the units of all the batches, who is responsible for the chain of custody (ensuring that the recall is carried out)?”

“The government is talking about creating guidelines, but nobody follows guidelines. What we need is, in the Drugs and Cosmetics Act, the force of law to effect such recalls,” Thakur said. He has raised this issue with the Health Ministry as well as filed a public interest litigation on this matter in 2016. The issue is currently a part of an ongoing case filed by him in Delhi High Court.

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