Shervotec Pharmaceuticals, which manufactures a range of medicines — including antioxidant capsules, folic acid and zinc tablets, D3 tablets, and cough syrups among other products — has been asked to shut down manufacturing after the inspection found “severe lapses”
It took “more than six hours” to enter the premises of Himachal Pradesh-based Shervotec Pharmaceuticals when a team of drug inspectors reached the premises for a surprise check.
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The Baddi-based drug makers, which manufacture a range of medicines — including antioxidant capsules, folic acid and zinc tablets, D3 tablets, and cough syrups among other products — have been asked to shut down manufacturing after the inspection found “severe lapses”.
“The observations coming out of the joint inspection are of a very serious nature and the issues coming out of the joint inspection have serious implications on public health,” Drug Controller General of India Rajeev Raghuvanshi wrote to the state drug regulator, highlighting 10 points raised in the investigation of the firm.
According to Raghuvanshi’s letter, dated June 16, the joint inspection team, especially the CDSCO representatives, were not allowed to enter the premises for six hours on April 27. “We do not know what transpired in these six hours inside the premises,” DCGI wrote in the letter, accessed by News18.
Shervotec Pharmaceuticals is one of the many drug units situated in Himachal Pradesh’s drug-making hub which is currently under scanner for violations of medicine safety standards. It is home to 71 pharmaceutical firms of India’s 209 firms which are shortlisted for risk-based inspections by the central government and drug regulatory agency Central Drug Standard Control Organisation (CDSCO).
WHAT PROBE REVEALED
In a surprising finding, the firm had no “operational quality management system”, raising doubts that the drugs manufactured were not even tested before releasing into the market.
DCGI wrote in the letter that the investigation found that “for most of the batches released, there was no supporting data available which raises serious data integrity issues for the batches going to market for consumption of patients”.
Also, it found that “no batch was tested for impurity”. “This amounts to data integrity issues — a major concern and threat to public health,” DCGI wrote.
Inspectors also noted that the firm was involved in illegal practices, the letter said. “CDSCO unapproved neutraceuticals were being manufactured in the same premises which is a serious violation of the D&C Act.”
Highlighting the mess and random manufacturing of medicines without any level of checks on medicines, the investigation found that “there was no functional quality assurance system” observed during the joint inspection.
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“The firm has no adequate controls on starting materials, intermediate products, bulk products and other in-process controls, calibrations and validations per the requirements of the rule…”
The team also found that there were “no analytical validations and manufacturing process validation records were available, which amounts to the use of non-validated analytical methods and manufacturing processes”. “It raises concern on the quality of the medicine being produced by the firm,” DCGI wrote.
Also, the firm’s microbiology laboratory was not in accordance with norms and there was “no approved microbiologist appointed by the firm”.
“No documentation was available to check the historical analysis performed which is as good as analysis not done.”
Raghuvanshi wrote: “The firm has not performed stability testing of the majority of the products manufactured in its facility and has even not maintained a record for the same.” He added: “It was not understood how firm assigned shelf life of manufactured products which is a violation of the requirements of Clause 16.12 of Schedule M of the Drugs & Cosmetics Act & Rules.”
Summarising the letter, DCGI said the firm was being run in total non-compliance with the Drugs and Cosmetics Act.
“Multiple NSQs (not of standard quality drugs) recorded in history are the proof of the complete failure of systems and procedures required for the production of quality medicine by any drug manufacturing organisation.”
CANCEL LICENCE, DCGI TELLS STATE REGULATOR
Expressing surprise and disappointment, Raghuvanshi wrote: “With all the serious violations which raise concern and risk to public health, surprisingly, the firm is still operational whereas other firms with similar non-compliances were either closed down or stop production orders were issued within a week of Joint Inspection by SLA (state licensing authorities).”
He mentioned that “on 7 June 2023, SLA forwarded the compliance report submitted by the firm”.
The report was found to be having no concrete corrective actions shown and responses to all the observations were “mostly open-ended, to be complied with in future”, he said. “In view of the seriousness of the matter, you are requested to immediately cancel the manufacturing licence of the firm rather than letting them run with all the non-compliances and continue to be a threat to public health. Manufacturing can start once the compliances are in place to run the organisation with required systems and procedures.”
Following the DCGI’s letter, the company was asked to “stop manufacturing” in a letter on June 17.
WHAT SHERVOTEC PHARMA SAYS
The mail sent to the company remained unanswered till the publishing of this report. Text messages sent to Munish Thakur, managing partner of the firm, also remained unanswered.
The website of the company claims that its products are “famous for their features such as effective, safe to use, easy to swallow, durable and exactly composed”.
The company claims that its pharmaceutical products are “highly demanded in chemist shops, hospitals, clinics and dispensaries and are also recommended by reputed doctors”.
It calls itself an “innovative and mature player” in the pharmaceutical industry and that is why the company has “decided to launch oncology products at national and international platforms”.
“Our expertise in the field and super speciality drugs contribute towards the consistent growth and success of the company.”
