Medical fraternity demands stricter monitoring of drugs by FDA

Members of the Indian Medical Association (IMA), Pune Chapter, have expressed concern stating that doctors prescribe medicines in good faith for their patients’ recovery and have no control over the manufacturing quality or composition or monitoring of the drugs available in the market.

PUNE: The recent occurrence – wherein ‘Coldrif’ cough syrup has been linked to the deaths of 19 children in Madhya Pradesh (MP) and Rajasthan and Dr Praveen Soni, a paediatrician from MP, has been arrested in connection with the case – has sent shockwaves through the medical fraternity, intensifying fear and uncertainty among doctors across the country.

Medical fraternity demands stricter monitoring of drugs by FDA

Members of the Indian Medical Association (IMA), Pune Chapter, have expressed concern stating that doctors prescribe medicines in good faith for their patients’ recovery and have no control over the manufacturing quality or composition or monitoring of the drugs available in the market. But they are still at legal and professional risk.

On Thursday, a meeting was held in this regard by members of the IMA Pune Chapter to discuss the issue of spurious, substandard, and unsafe drugs, and the urgent need for stricter monitoring by the Food and Drug Administration (FDA).

“Doctors are now fearful. Our role is to treat patients, but such incidents make us question the safety of the drugs we prescribe. Despite having no control over it, we can still face unfortunate legal action,” said Dr Sunil Ingale, president of the IMA Pune Chapter.

Coldrif cough syrup, marketed by Sresan Pharmaceuticals, Kanchipuram, Tamil Nadu, has been in the news as its consumption allegedly led to the deaths of 19 children in MP and Rajasthan, following renal complications. Last week, the health ministry said that samples of Coldrif were tested by state authorities and found to contain DEG (diethylene glycol) exceeding permissible limits. Diethylene glycol is a toxic solvent used in industrial products and can cause kidney impairment, said officials.

Some doctors have now even started prescribing medicines by their generic name to avoid accountability for specific brands. However, the IMA clarified that this cannot be a long-term solution to the problem.

The association has demanded that the FDA strengthen drug monitoring and inspection mechanisms at the local level. It has urged authorities to ensure that only thoroughly tested and approved drugs reach pharmacies and hospitals.

During the Thursday meeting, doctors also emphasised the need for stricter enforcement of the rule prohibiting over-the-counter (OTC) sales of prescription medicines such as cough syrups. “Many people buy these syrups without consulting a doctor. In most cases, common colds resolve without medication. These drugs should be sold only with a valid prescription,” said Dr Sanjay Patil, national secretary, Hospital Board of India.