The top drug makers in India have appealed to the Drug Controller General of India (DCGI), the country’s apex drug regulator, for a “fair chance” before declaring the names and list of unusual quality drugs publicly.
The Indian Pharmaceutical Alliance (IPA), a lobby of top drug makers like Glenmark, Cipla, Dr Reddy’s, Alkem, Alembic, Cadila, and Intas, among others, has requested the regulator for a fair chance to cross-check the quality of a drug’s control sample and submit the report before the drug alert is published.
The latest alert, issued by the Central Drugs Standard Control Organisation (CDSCO) on its website, has flagged 48 medicine batches failing the quality parameters in March out of the total 1,497 samples tested. It includes drugs manufactured by medium to large pharma companies such as Nestor Pharmaceuticals, JBJM, Ronam Healthcare and Glenmark Pharmaceuticals.
Glenmark has informed the regulator that the highlighted medicine is a counterfeit product and has not been manufactured by the company.
Highlighting a similar concern on behalf of the industry, Sudarshan Jain, secretary general of IPA, wrote to DCGI Rajeev Singh Raghuvanshi, saying: “There have been instances where CDSCO officials have themselves caught the counterfeit version, and despite it, the product was reported as NSQ (not of standard quality).”
Not-of-standard quality (NSQ) drugs can adversely impact the quality of treatment and cause harm to patients, besides contributing to the emergence of drug resistance and the spread of the disease.
The alerts are used by the government to seek cues and conduct investigations at manufacturing units that are frequently failing quality checks. The Ministry of Health and Family Welfare is already conducting massive nationwide audits and raids at several drug manufacturing units to fix the gaps in good manufacturing practices.
In his letter, Jain described the current process as “outdated” and recommended a few changes such as “validating the genuineness” of drug products before public announcement.
He claimed that the declaration of NSQ on the website without validating the genuineness damages the reputation of the industry. The letter, dated April 26, requested the regulator to review the current process of publishing the NSQ list.
“Today, the NSQ reports received from the government analytical labs are immediately uploaded on the website without prior investigation and ascertaining the facts about the origin.”
“This process is outdated (DCC guidelines on NSQ drugs approved in 1993) and does not involve seeking confirmation from the bonafide manufacturer…” Jain said.
The Recommendations
The industry has suggested to Raghuvanshi that before the drug alert is published, the company should be given a fair chance to cross-check the quality of its control sample and submit the report.
“A portion of the impugned sample along with all backup data of failure should also be provided to the bonafide manufacturer for test and analysis at their end.”
The industry further suggested that in cases where a retailer is unable to provide invoices for the sale or purchase of a product or the product is found in suspicious circumstances without a proper invoice, the situation should be dealt with differently and “extra steps need to be taken to declare it as NSQ”.
The industry has also requested to insert the provision of a showcause notice.
“The principle of natural justice, a showcause notice should be issued to explain the manufacturer’s position,” Jain said in the letter.
The letter concluded that the Indian pharmaceutical industry has a sizeable export market and the drugs are registered in the international markets.
Jain also appreciated the CDSCO’s effort in undertaking reforms, especially since the Covid-19 pandemic, including various measures taken in the interest of public health outcomes.
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