Karnataka to come out with first-ever NSQ Recall Policy to ensure speedy withdrawal of substandard medicines

Karnataka government is now preparing its new NSQ (not of standard quality) Recall Policy to support the speedy withdrawal of substandard medicines from the market. This according to the state government is the first- of-its-kind in the country.
This move by the government is in sync with the Drugs Consultative Committee (DCC), endorsing to bring in stringent norms to be enforced in taking action on the samples of drugs declared as spurious or NSQ.
According to Karnataka health and family welfare minister Dinesh Gundu Rao, “We are pacing up to introduce a robust recall mechanism to remove sub-standard batches of medicines from the market immediately. This would bring in the much-needed transparency and efficiency to strengthen our supply chain.”
A first step to this policy is the development of software with details of all retailers, wholesalers, manufacturers and their authorised representatives to trace the availability of the stocks of NSQs at every stage which would be implemented very soon. The time-line was not disclosed.
In fact, there is a regular practice of surprise inspections by the state drugs control department, where the medicines are picked up at random from the pharmacy outlets, are tested at the Drugs Testing Labs (DTLs) at Bengaluru, Belgaum and Hubballi and then warnings are issued for recall and the companies will be penalised if they fail to comply with the government order.
Noting that the state health department could withdraw such contaminated drugs from its hospitals, the lacunae is that there is no system in place as of now to recall them from private healthcare providers. In the absence of a central drug recall policy so far, which the DCC has now taken into cognisance we now seen the critical need of a dedicated NSQ policy to stall the circulation of such medicines, he said.
If a batch of medicines is found spurious or NSQ, the manufacturing and distribution license should be suspended until corrective actions are taken. The incident of the West Bengal pharma firm Paschim Banga Pharmaceutical Ltd., supplying substandard Ringer’s lactate resulting in maternal case fatalities in Ballari district in November 2024 stands as stark reality to the situation. It further makes it imminent for strong preventive measures to avoid such incidents going forward, stated Minister Rao.
In fact, Karnataka government recently raised the issue to the Union health ministry for a system to share alerts on drugs failing quality tests. This is in a bid to address the distribution of substandard injectable drugs that have failed sterility tests between January 1 to February 16, 2025, he added.
The need of the hour is to bring out NSQ Recall Policy in a time-bound manner. This will ensure strict penalties, including heavy fines and imprisonment, for those involved in the manufacture and distribution of spurious drugs.
The issue of narcotics and psychotropic substances has been a challenge too. For this a special drive was conducted in the state where of the 488 pharmacy outlets investigated, show cause notices were issued to 400 stores, 231 licenses were suspended and three licenses were cancelled.
With the threat of anti-microbial resistance looming large, a two day special drive was held in mid-February to check the misuse and sale of antibiotics across pharmacy outlets which revealed at least 52 stores sold these medicines without prescriptions.
Enforcing the NSQ Recall Policy with stringent norms will enhance drug quality, ensure public safety, and deter unethical pharmaceutical practices, he said.
Source : Pharmabiz