The Central Drugs Standard Control Organisation (CDSCO) has flagged certain batches of two drugs as counterfeit and identified 111 other drugs and formulations as not meeting standard quality (NSQ) requirements in its November 2024 report. Among the counterfeit drugs listed are Pan D, a popular medication marketed by Alkem Laboratories, and the antibiotic Augmentin 625 Duo, distributed by GlaxoSmithKline Pharma.

The CDSCO report does not name the manufacturers responsible for the flagged batches. Instead, it states that the listed companies have denied producing the identified batches, suggesting these products are counterfeit. "The stated manufacturers have confirmed that they did not produce the implicated batches, indicating the products are likely spurious. However, this remains subject to the outcome of ongoing investigations," the CDSCO noted.

According to the Union Health Ministry, the counterfeit drugs were produced by unidentified and unauthorized manufacturers who misused established brand names. An investigation has been initiated to address the issue. The CDSCO emphasized that drug samples are routinely collected from sales and distribution points as part of ongoing regulatory surveillance. The results are published monthly to inform stakeholders and the public about counterfeit drugs detected in the market.

Of the 111 drugs categorized as NSQ in November, 41 were identified by central drug laboratories, while the remaining 70 were flagged by state-level drug testing facilities. NSQ drugs fail to meet the quality benchmarks established by national or international standards. Examples include hypertension medication Ozomet PG2 tablets by Ozone Pharmaceuticals, Tofajak tablets for rheumatoid arthritis from Cipla, and Monit SR30 tablets for chest pain manufactured by Intas Pharma.

Most of the substandard drugs this month were traced back to manufacturing facilities in cities such as Ahmedabad, Baddi (Himachal Pradesh), Puducherry, and Haridwar and Roorkee in Uttarakhand. The Health Ministry also highlighted that November saw increased participation from states in reporting NSQ cases to the central database, which will help strengthen the overall quality control system. "Greater reporting of NSQ and counterfeit drugs from states to the central database will further enhance the availability of high-quality medicines across the nation and globally," the ministry stated.

In addition to the substandard drugs, two counterfeit samples were flagged in November. One was identified by the Bihar Drugs Control Authority and the other by CDSCO Ghaziabad. These samples were reportedly produced by unauthorized entities using the brand names of legitimate companies.

Authorities reiterated that identifying and removing NSQ and counterfeit medicines is an ongoing effort, carried out in collaboration with state regulators, to ensure public safety. Officials also clarified that the NSQ classification applies only to the specific batches tested and does not imply concerns about other batches of the same product available in the market.

(Input from various sources)

(Rehash/Sai Sindhuja K/MSM)