The company, in an exchange filing, said it conducted extensive research comparing samples collected by the CDSCO with the actual batches of both products manufactured by Alkem and discovered that the samples collected by CDSCO were fake and not manufactured by Alkem.
“The conclusion is based on the differences observed between the CDSCO samples and the actual batches manufactured by Alkem in terms of physical appearance, color and text on the labeling of the two products,” he said.
Alkem submitted a response to the CSDCO along with the assessment report which confirmed that the samples collected by CDSCO are spurious and not manufactured by the company.
“To address the issues of spurious drugs, Alkem has incorporated unique features and QR codes on the packaging of Pan-D and Clavam 625, which separates genuine products from spurious ones,” the company further said.
CDSCO points out quality problem
India’s central drug regulatory authority on Thursday listed samples of more than 50 drugs, including paracetamol, Pan D, calcium and vitamin D3 supplements and anti-diabetes pills, as “not of standard quality” in its latest report. The batches of drugs flagged by the Central Drugs Standard Control Organization (CDSCO) in its August drug alert are from companies such as Alkem Laboratories, Hindustan Antibiotics Limited, Hetero Labs Limited, Karnataka Antibiotics and Pharmaceuticals Ltd, Nestor Pharmaceuticals Ltd, Priya Pharmaceuticals and Scott-Edil Pharmacia Ltd. CDSCO’s August drug alert included batch samples of medications such as Shelcal, Vitamin B Complex with vitamin C softgels, tablets of vitamin C and D3 and ciprofloxacin tablets.
The high blood pressure drugs Telmisartan and Atropine Sulfate and antibiotics such as Amoxicillin and Clavulanate Potassium Tablets have also been classified as “not of standard quality”.
While batches of some drugs failed the “dissolution test” under the Indian Pharmacopoeia and failed the “assay” and “water” test under IP, some were identified as fake or having volume uniformity issues.
According to an official source, a list of medicines that “are not of standard quality” is published every month.
“Drugs are constantly monitored by the drug regulator and samples are randomly tested every month to ensure their quality and safety standards. When it is found that they are not of standard quality, appropriate action is taken against the manufacturing companies,” the agency said. fountain.
According to the CDSCO, the drug licensing authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim and Tamil Nadu, they have not submitted any data regarding the non-standard quality (NSQ) alert of August 2024.
Pondicherry, Telangana, Delhi, Uttarakhand, West Bengal, Andaman and Nicobar, Dadar and Nagar Haveli, Daman and Diu and Lakshadweep have also not submitted data, it said.
(With contributions from agencies)
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