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CDSCO declares 59 drugs tested in August as Not of Standard Quality
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Gireesh Babu, New Delhi
September 28 , 2024
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The Central Drugs Standard Control Organisation (CDSCO) has released a list of 59 drug samples declared as Not of Standard Quality (NSQ) during the month of August, with samples of drugs labelled as manufactured by some of the major companies failing the quality test.
The State drug regulators have reported 11 NSQs to the CDSCO in the prescribed format, while CDSCO released the list of 48 NSQs during the month. During the month also, 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 August include samples of Clavam 625 (amoxicillin and potassium clavulanate tablets), and Pan-D (pantoprazole gastro-resistant and domperidone prolonged-release capsules) labelled as manufactured by Alkem Health Science, Cepodem XP50 dry suspension (cefpodoxime proxetil and potassium clavulanate oral suspension) labelled as manufactured by Hetero Labs Ltd, among others.
Samples of paracetamol tablets 500 mg labelled as manufactured by public sector undertaking Karnataka Antibiotics and Pharmaceuticals Ltd, and metronidazole tablets 400 mg from another public sector undertaking Hindustan Antibiotics Ltd, also were declared as NSQ during the month by the CDSCO.
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 two ayurvedic drugs - Haridrakhandam and Yogaraja Guggulu - labelled as manufactured by Kerala-based Bhaskara Vilasam Vaidyasala, cefixime oral suspension (dry syrup) and frusemide injection 20 mg labelled as manufactured by Nestor Pharmaceuticals, Faridabad, 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, 2024 as per DCG(I) Circular dated February 9, 2024, said the CDSCO.
The Union Territories which failed to submit the data include Delhi, Puducherry, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, and Lakshadweep.
Besides, NSQ data was not received as per the format in Excel sheet prescribed by the DCGI's circular from the State Drugs Licensing Authorities of Karnataka, Kerala and Jammu Kashmir for the month of August, added the central drug regulator.
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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