Updated: October 9, 2019 3:02:47 am
India’s top drug regulator has asked companies manufacturing an abdominal painkiller combination, which it approved nearly a decade ago, to submit post-marketing data to prove its safety and effectiveness for a specific indication in the Indian population.
The move comes nearly seven years after a Parliamentary committee flagged the drug’s clinical trial approvals as “outrageous” case of a potential nexus between pharmaceutical companies and experts important to the regulator’s approval process. It further follows a decision by the manufacturer that first received the approval to surrender its licence for the product. Its approval is also a topic of contention in an ongoing case at the Delhi High Court by public health activist and Ranbaxy whistleblower Dinesh Thakur.
The medication, a fixed dose combination (FDC) of aceclofencac and drotaverine, was initially approved by the Central Drugs Standard Control Organisation (CDSCO) on September 15, 2008, stated a letter to all state drug controllers last month, which The Indian Express has reviewed.
However, the Parliamentary Standing Committee on Health in 2012 flagged the drug for “shortcomings” in its approval process.
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According to the panel, the FDC “did not have permission for sale in any of the major developed countries” and no “special or specific relevance to the medical needs of India”.
Following this, the government referred the combination to a new drug or subject expert committee (NDAC/SEC) “for examination and review.”
Move to ensure safety of drug for Indian populace
The move may help ensure that this combination is a safe and effective painkiller for the Indian population, considering that serious questions were raised earlier about its approval process. The Parliamentary panel on approval noted “... an official of the CDSCO advised the manufacturer ... to not only select experts but also get their opinions and deliver them to the office of the DCGI. No wonder that many experts gave letters of recommendation in identical language apparently drafted by the interested drug manufacturer.”
“Based on the recommendations of the Subject Expert Committee, it was decided that the FDC of Aceclofenac 100 mg + Drotaverine Hydrochloride 80 mg tablet shall be indicated for treatment of ‘colicky pain due to smooth muscle spasm’ for its continued marketing,” stated Drug Controller General of India (DCGI) V G Somani in his September 19 letter. However, its manufacturers were directed to conduct trials, and SEC asked the company that first received the licence for the product “to revise the indication and submit the clinical trial protocol for conducting the study.”
“However, after a series of communications, M/s Themis Medicare finally surrendered the product licence,” stated the DCGI.
Yet, the proposal was “again re-deliberated” in the reproductive and urology SEC’s meeting, he added. “After detailed deliberation, the committee recommended that the firm(s) may be directed to conduct Active Post Marketing Surveillance in minimum 200 patients and the study should include patients of primary dysmenorrhea, biliary colic and ureteric colic. The study should be completed within one year and results…should be placed before the committee for further review,” he stated. Somani directed states to conduct this surveillance “for the treatment of colicky pain due to smooth muscle spasm”.
The Parliamentary panel that scrutinised the combination’s approval had taken issue with the fact that its trials were conducted “only in Maharashtra”. Among the cases it listed “to prove the apparent nexus that exists between drug manufacturers and many experts whose opinion matters so much in the decision making process at the CDSCO”, the committee said that “nothing can be more outrageous” than the clinical trial approval granted for this FDC.
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