August 24,2024
The Central Drugs Standard Control Organisation (CDSCO) has released a list of 70 drug samples declared as Not of Standard Quality (NSQ), with samples of drugs labelled as manufactured by some of the major companies failing the quality test.
The State drug regulators have reported 13 NSQs to the CDSCO in the prescribed format, while CDSCO released the list of 57 NSQs during the month. During July also a large number of States and Union Territories did not submit any data related to NSQ alert to the CDSCO, it reported.
The list of drugs failed the quality test by the CDSCO and Central Laboratories during the month of July include samples of budesonide nebuliser suspension BP (Budecort Respules) and tamsulosin and dutasteride tablets (Urimax-D) labelled as manufactured by Cipla Ltd, amoxycillin and potassium clavulanate tablets IP (Pressclav625) labelled as manufactured by Aurobindo Pharma, and carboplatin USP labelled as manufactured by Hetero Labs.
Samples of compound sodium lactate injection (Ringers Lactate Solution for Injection) labelled as manufactured by public sector enterprise Hindustan Antibiotics Ltd, and ofloxacin and ornidazole tablets and paracetamol tablets IP 650 mg labelled as manufactured by Karnataka Antibiotics and Pharmaceuticals Ltd were also declared as NSQs 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 new improved gentle daily care natural protein shampoo labelled as manufactured by Himalaya Wellness Company, and several drugs supplied by Kerala Medical Services Corporation, 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, West Bengal have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of July, 2024 as per DCG(I) Circular dated February 9, 2024, said the CDSCO.
The Union Territories which failed to submit the data include Delhi, Pondicherry, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, 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 and Jharkhand for the month of July, 2024.
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. Interestingly, the CDSCO also stopped publishing the drugs which are suspected or reported as spurious, while the data was part of its earlier data format.
The 63rd Drugs Consultative Committee (DCC) meeting held at the end of January sought the State drug regulators to submit data related to NSQs and spurious drugs on a monthly basis. The committee also mooted preparing a list of manufacturers who repeatedly produce NSQ drugs and black list them.
The Committee also noted that only a few states are sharing the NSQ data with the central authority on a monthly basis and called for all the States to share the data periodically and in a timed manner for publication on the website.
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.
Source: Pharmabiz