Prescribes Raids on Erring Pharma Firms, Health Ministry has asked the DCGI to rid India of low-quality medicines

According to News18.com, the Narendra Modi administration is considering a major effort to begin surprise inspections of pharmaceutical companies’ production sites whose medications have failed quality assessments more than twice in the last year. According to government sources familiar with the situation, the office of union health minister Mansukh Mandaviya has directed the Drugs Controller General of India (DCGI) to “make India free of spurious and poor quality medicines.”

The health ministry has requested that VG Somani, the drug regulator, organise a task team to investigate the facilities across states.

“Now that India has recovered from the Covid-19 outbreak and has a high immunisation coverage, we feel India is secure.” “It’s time to move on to other endeavours, such as cleaning up the Indian medicines business of counterfeit and low-quality items,” a top government source told News18.com. “The health minister has taken the initiative, and he has directed the DCGI to look for pharmaceutical corporations whose medications are failing quality checks on a regular basis.”

KEEPING CHECK

The government inspects pharmaceuticals on a regular basis to assess if they are of acceptable or unacceptable quality (NSQ). The Central Pharmaceuticals Standard Control Organisation, the country’s main drug regulatory organisation, keeps a list of these drugs up to date on their website (CDSCO). In January, for example, 1,227 samples were analysed, with 27 medicines being designated NSQ. “Approximately 2% of the total samples gathered failed the audit, necessitating prompt care,” the officer stated. These goods failed the test for a variety of reasons, including dissolution, disintegration, and chemical content homogeneity.

The problem was noted in a study released in 2019 by the United States Trade Representative (USTR), which claimed that about 20% of all pharmaceutical items supplied in India are counterfeit or spurious.

Given India’s rapidly developing pharmaceutical sector and its decades-long reputation as the “pharmacy of the world,” this was seen as a damning assertion.

WHAT IS THE PLAN?

The DCGI office is expected to form a task group, as requested by the minister, according to a top government official.

“The minister’s office has asked the DCGI to go after all pharmaceutical companies that produce low-quality pharmaceuticals on a regular basis.” The government’s new goal is to rid India of fake medications, according to the official.

The task force, which will be created under the DCGI, will be responsible for a variety of tasks, including raiding manufacturing locations, verifying for compliance with production standards, and collecting samples from the sites.

“The manufacturer will be seriously penalised if these samples fail to pass the inspections,” the source stated.