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The Central Drugs Standard Control Organisation (CDSCO) has released a list of 67 drug samples declared as Not of Standard Quality (NSQ) during the month of September, of which a majority was tested by the CDSCO or central laboratories.
The State drug regulators have reported 18 NSQs to the CDSCO in the prescribed format, while CDSCO released the list of 49 NSQs during the month. A large number of States and Union Territories did not submit any data related to NSQ alert to the CDSCO, despite repeated sensitisation from the Drugs Consultative Committee (DCC).
The list of drugs failed the quality test by the CDSCO and Central Laboratories during the month of September include samples of Pan 40 (pantaprazole gastro-resistant tablets) and Clavam 625 (amoxicillin and potassium clavulanate tablets), labelled as manufactured by Alkem Health Science; Ciprodac 500 (ciprofloxacin tablets) from Cadila Pharmaceuticals; Zerodol-SP (aceclofenac 100 mg, serratiopeptidase 15 mg and paracetamol 325 mg tablets) from Ipca Laboratories; and paracetamol paediatric oral suspension labelled as manufactured by Vivmed Labs Ltd.
Samples of metronidazole 400 mg tablets, and diclofenac sodium 50 mg tablets labelled as manufactured by public sector undertaking Hindustan Antibiotics Ltd (HAL), also was declared as NSQ during the month by the CDSCO. It may be noted that sample of metronidazole 400 mg from HAL was declared as substandard in the month of August also, by the drug regulator.
Even though the labels claim major companies as manufacturers of these failed products, in the past, some of these companies have informed the regulator that the samples were not manufactured by them and are spurious drugs.
The list of drug samples declared as NSQ by the state laboratories include ayurvedic drug Yogaraja Guggulu labelled as manufactured by Kerala-based Oushadhi, The Pharmaceutical Corporation. Frusemide injection 20 mg labelled as manufactured by Nestor Pharmaceuticals, Faridabad, a sample of which was also declared as NSQ last month.
The other drugs declared as NSQ during September by the State laboratories include telmisartan 40 mg tablets, pantaprazole injection 40 mg, glimepiride tablets, cough syrup, among others.
State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Telangana, Uttarakhand, and West Bengal have not submitted any data in respect of the NSQ alert for the month of August, despite the circular from the Drugs Controller General (India) in February 9, 2024.
The Union Territories which failed to submit the data include Delhi, Puducherry, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, and Lakshadweep.
It may be noted that the CDSCO has changed its data releasing format related to NSQs for the public, from the month of May, and started publishing the names of States and Union Territories which are not submitting the monthly data on NSQ to the Central drug regulator in the stipulated format within the time limit.
The 64th Drugs Consultative Committee (DCC) meeting held in the second part of June, this year, has once again sought the State drug regulators to submit data related to NSQs and spurious drugs on a monthly basis.
The meeting, while considering the action taken report of the 63rd DCC meeting held in January, this year, was apprised that only few States are sending the NSQ data on monthly basis despite repeated requests to submit the data in a timely manner in prescribed format.
"All the States were sensitised to look into the matter and to send the NSQ data periodically and in a timely manner, so as to publish the same on the website for information of all the stakeholders," said the Committee in its latest meeting.
The 63rd Committee meeting also mooted preparing a list of manufacturers who repeatedly produce NSQ drugs and black list them.
During the meeting, the Central drug regulator sensitised all the States to look into the matter regarding any difficulties and to send the NSQ data periodically and in a timely manner, so that the information can be compiled and published on the website for the attention of all the stakeholders.
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