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Gireesh Babu, New Delhi February 23 , 2023
The Central Drugs Standard Control Organisation (CDSCO) has declared almost five per cent of the drug samples it tested during the month of January as Not of Standard Quality (NSQ), including some of them labelled as manufactured by Sun Pharma Laboratories, Cipla Ltd, Torrent Pharmaceuticals, Glenmark Pharmaceuticals, Alkem Health Science, IPCA Laboratories and Eris Lifesciences, among others.

The drug control authority has conducted tests on 1,348 samples during the month of January, 2023, and declared 67 as NSQs while 1,281 samples are declared as meeting standard quality. The percentage of NSQ in the total number of samples tested was around three to four per cent earlier, but has inched up to around five per cent in the recent few months.

The NSQs listed by the CDSCO include a sample of Pantocid DSR, a combination of pantoprazole gastro-resistant and domperidone prolonged release to treat gastroesophageal reflux disease and peptic ulcer, from Sun Pharma Laboratories which was drawn by the drug regulator’s East Zone office in Kolkata and reported as filed in identification and assay tests.

Sun Pharma has already notified the drug regulator regarding the availability of spurious or counterfeit of the said batch of drug. The CDSCO is conducting further investigation on the samples drawn during the raid in January, said the drug regulator.

The other drug samples which the CDSCO listed as manufactured by the major pharma firms include another gastrointestinal reflux drug Pan D (pantaprazole gastro-resistant and domperidone prolonged release capsule IP) from Alkem Health Science, a unit of Alkem Laboratories; anti asthmatic drug Budecort Respules 0.5 mg (budesonide nebuliser suspension BP) from Cipla Ltd; diabetes drug Ziten (teneligliptin tablets IP 20 mg) from Glenmark Pharmaceuticals; anti-inflammatory drug Chymoral forte tablets (trypsin-chymotrypsin tablets) from Torrent Pharmaceuticals; pain killer Zerodol TH 4 tablets (aceclofenac 100 mg and thiocolchicoside 4 mg) from IPCA Laboratories; anti-diabetic combination drug GlimiSave M2 tablets (metformin hydrochloride prolonged-release and glimepiride tablets IP) from Eris Lifesciences Ltd.

Public sector manufacturer Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), which has been named in almost all the monthly drug alert lists by the CDSCO for NSQ drug samples, is also reported with a couple of drug samples tested as NSQ in January. KAPL’s ciprofloxacin hydrochloride E tablets IP 500 mg, and metronidazole tablets IP 400 mg were reported as NSQs during the month.

Adhesive manufacturing major 3M India’s adhesive tape USP (micropore surgical tape) has failed in tensile strength test, while Vivimed Labs' atorvastatin and aspirin capsules (10/75) failed in dissolution of atorvastatin during the test.

While the test also identified a loose powder purported to be containing telmisartan, with no details of batch number, manufacturing date, expiry date or manufacturer, and another loose yellow coloured tablets purported to contain rosuvastatin 10 mg without batch number, manufacturing or expiry dates and manufacturing attributed to the premises of Himachal-Pradesh-based Trizal formulation, according to the CDSCO’s drug alert list, no samples of spurious or misbranded drugs were there during the month.

According to the ministry of health and family welfare (MoHFW), the number of drug samples declared as NSQ by the regulators during the year 2021-22 was a meagre 2.86 percent, at 2,545 samples out of a total 88,844 samples tested during the year. A total of 379 drug samples, highest in eight years, were declared as spurious or adulterated and 592 prosecutions were launched for manufacturing, sale and distribution of spurious or adulterated drugs. During the year 2021-22, 450 persons were arrested related to the spurious adulterated drugs cases, the highest number of cases in eight years from 2014-15.

The drug regulators have conducted 15,973 raids during the year 2021-22, as compared to 20,922 in 2020-21, 15,641 in 2019-20 and 33,492 in 2018-19.

Bharati Pravin Pawar, minister of state in the MoHFW, recently stated in the Rajya Sabha that the government has taken various regulatory measures to ensure the quality of medicines in the country including notification for affixing Bar Code or Quick Response Code in active pharmaceutical ingredients (APIs) and some drug formulations, increase in sanctioned regulatory posts of CDSCO and notification providing marketers of any drug to be responsible for its quality.

As part of preventing spurious drugs from the market, testing capacities of Central Drugs Testing Laboratories under CDSCO have been strengthened, and Drugs and Cosmetics Rules, have been amended making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of product manufacturing license by the Authority, and that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of drugs falling under the Category II and Category IV of the biopharmaceutical classification system.

“The Central government has provided Rs. 651.97 crore for strengthening the drug regulatory system including upgradation of existing state laboratories, setting up of new drug testing laboratories and upgradation of existing State Drug Control Offices as part of ‘Strengthening of State Drug Regulatory System’,” said the minister.

A National Drug Survey was conducted in the year 2014-16. Out of a total of 47,012 drug samples drawn from both government and private sources, the percentage of NSQ and spurious drugs from Retail outlets was 3% and 0.023% respectively, while that from government sources was 10.02% and 0.059% respectively, added the minister.

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