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61 drug samples tested by states and CDSCO reported as NSQs
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Gireesh Babu, New Delhi
July 23 , 2024
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The state drug testing laboratories of Maharashtra and Kerala have reported 23 samples and seven samples, respectively, tested in the month of June as Not of Standard Quality (NSQ) including some Ayurveda drug formulations.
For at least the third consecutive month, almost 22 State Licensing Authorities (SLAs) and licensing authorities of four Union Territories failed to submit the NSQ alert data to the central drugs regulator, said CDSCO. The CDSCO laboratories, during the month, reported that 31 drug samples tested by its facilities turned out to be NSQs.
"State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Pondicherry, Telangana, Delhi, Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of June, 2024 as per DCG(I) Circular dated February 9, 2024," said the CDSCO.
NSQ data received from the SLAs of Rajasthan and Odisha were not in the format and software as instructed by the Drugs Controller General (India), it added.
The drug samples failed standard test conducted by the laboratories in Maharashtra include Caditral 100 (itraconazole capsule BP.100 mg) labelled as manufactured by Glenmark Pharmaceuticals, Lytraco 200 (itraconazole capsules 200 mg) labelled as manufactured by Sterlife Pharma, Montor-LC tablet (montelukast sodium and levocetrizine dihydrochloride tablet IP) as manufactured by Torque Pharmaceuticals, Monticet-L tablets (montelukast and levocitrizine hydrochloride tablets) as manufactured by Ticoma Pharmacia, levocetrizine dihydrochloride and montelukast sodium tablets IP from Bajaj Formulations, among others.
Those failed the tests in the Drugs Testing Laboratory, Thiruvananthapuram include losartan potassium tablets IP 50 mg labelled as manufactured by public sector undertaking Hindustan Antibiotics Ltd, liquid paraffin IP repacked by Kerala State Drugs & Pharmaceuticals, Haridrakhandam and Yogarajaguggulu, to Indian Systems of drugs labelled as manufactured by Bhaskaravilasam Vaidyasala, Thiruvananthapuram.
Drugs failed the quality test conducted in the CDSCO and central laboratories include samples of propylene glycol IP labelled as manufactured by Manali Petrohemicals and Balaji Amines Ltd, glipizide and metformin tablets IP (Glynase-MF) labelled as manufactured by USV Pvt Ltd, compound sodium lactate injection IP 500 ml (Ringer lactate solution for injection) labelled as manufactured by Vision Parenteral, esomeprazole gastro-resistant tablets 40 mg (Esomedge 40) labelled as manufactured by Glensmith Labs Pvt Ltd, gentamicin sulphate injection 2 ml labelled as manufactured by Zee Laboratories, among others.
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 Central drug regulator in May said that 21 States and four UTs did not submit the data in respect of NSQs and spurious alerts in the month of April, May and now, June. It has also released the names of the SLAs who failed to submit the monthly data.
It may be noted that 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 Not of Standard Quality (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.
Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) (DCGI) during the meeting highlighted the concerns with respect to multiple NSQ drugs manufactured by the same manufacturer, and the need to watch such repeated offenders in future.
“It was discussed about black listing of such manufacturers and preparing a list of such offenders so that the Government procurement agencies become careful before procurement of drugs from such manufacturers,” said the drug regulator.
The Committee also looked at the status of the recommendation made with regard to the sharing of information on NSQs in the previous meeting. It observed that only a few states are sending the NSQ data on a monthly basis. 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.
Following this, the DCGI has also issued a letter on February 9, 2024, to the SLAs seeking the requirement to file the data in a prescribed format within a timeline every month.
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