Five States Account For 68% Of NSQ Drug Samples In September: CDSCO

Five states accounted for nearly 68% of the 288 drug samples declared Not of Standard Quality (NSQ) by state drug testing laboratories in September, according to data released by the Central Drugs Standard Control Organisation (CDSCO).

Uttar Pradesh reported the highest number of such samples at 64, followed by Tamil Nadu (43), Kerala (35), West Bengal (31) and Karnataka (24). Together, the five states accounted for 197 of the 288 NSQ samples identified by state laboratories.

The CDSCO declared a total of 330 drug samples tested across the country during September as NSQ. Of these, 288 were identified by state drug testing laboratories, while the remaining samples were reported through other testing mechanisms.

The list includes samples bearing the labels of several major domestic pharmaceutical companies, including Intas Pharmaceuticals, Mankind Pharma, Sun Pharma Laboratories, J B Chemicals and Pharmaceuticals, Glenmark Pharmaceuticals and Macleods Pharmaceuticals. Products associated with multinational companies Eli Lilly and Baxter were also listed.

The regulator clarified that an NSQ finding applies to the specific batch tested and does not automatically raise concerns about other batches or products of the same brand.

"Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. The failure is specific to the drug products of the batch tested by the government laboratory, and it does not warrant any concerns on the other drug products available in the market," the CDSCO.

Among the samples listed were three batches of levetiracetam 500 mg tablets, along with samples of gabapentin 100 mg tablets, tamsulosin hydrochloride modified-release tablets and a combination of tamsulosin hydrochloride and dutasteride, labelled as manufactured by Intas Pharmaceuticals.

The list also included olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, and two samples of L-carnitine L-tartrate, mecobalamin and folic acid tablets labelled as manufactured by Mankind Pharma. Samples of ursodeoxycholic acid tablets and clopidogrel and aspirin capsules bearing the Sun Pharma Laboratories label were also declared NSQ.

Two samples of thyroxine sodium tablets of different strengths from Macleods Pharmaceuticals were among those that failed quality tests. Glenmark Pharmaceuticals had samples of telmisartan and metoprolol succinate extended-release tablets and telmisartan 40 mg with amlodipine 5 mg tablets on the list. Samples of Nicardia Retard 10 tablets and nifedipine sustained-release 10 mg tablets labelled as manufactured by J B Chemicals and Pharmaceuticals were also flagged.

The list further included four strengths of Mounjaro KwikPen, an injectable medicine used for diabetes and weight management, labelled as manufactured by Eli Lilly Italia Spa and imported by Eli Lilly and Company (India) Pvt Ltd. Two peritoneal dialysis solutions containing 1.5% and 2.5% dextrose, labelled as manufactured by Baxter Manufacturing (Thailand) and imported by Baxter (India) Ltd, also failed testing standards.

Separately, a sample of lactic acid bacillus tablets (120 M), sold under the brand name Sporlac-DS, was declared spurious. The manufacturer named on the label informed the drug regulator that it had not manufactured the batch in question.

The findings come amid a proposed tightening of regulatory action against drugs that fail critical quality tests. Earlier this month, the Union Health Ministry proposed amendments to the Drugs Rules, 1945, to provide for immediate suspension of manufacturing licences when a drug fails specified critical quality parameters.

Under the draft proposal, the Central Licensing Approving Authority or the State Licensing Authority, as applicable, could suspend the licence of the concerned drug upon receiving a government analyst's report declaring it NSQ on grounds such as assay, dissolution, related substances, impurities or sterility.

The suspension would remain in force until the manufacturer completes a root cause analysis and takes Corrective and Preventive Action (CAPA) to the satisfaction of the licensing authority.

The proposal also provides for the Government Analyst's report to be shared with the Drugs Controller General of India, the relevant state or union territory licensing authority, and the manufacturer and marketer of the drug.

Pharmaceutical manufacturers, however, have argued that an NSQ finding can arise from factors beyond manufacturing defects. These may include improper storage and distribution, temperature fluctuations during transit, particularly in summer, variations between laboratories or analytical methods, and degradation of products after they leave the manufacturing facility.

The distinction is important because identifying the cause of a quality failure is essential to deciding whether the problem lies in manufacturing, testing or the supply chain.

At the same time, the proposed changes seek to ensure that drugs failing critical quality parameters are dealt with promptly to protect patients.