New Delhi, Sept 26: In a concerning development, the Central Drugs Standards Control Organisation (CDSCO) has declared over 50 widely-used drugs, including paracetamol, Pan D, and calcium supplements, as “not of standard quality” in its August 2024 report. This has raised significant safety concerns for millions of patients relying on these medications.
The drugs flagged include essential medicines such as paracetamol, vitamin D and calcium supplements, hypertension medications, and certain anti-diabetic pills. The list, part of the “Not of Standard Quality (NSQ) Alert” category, was compiled based on random monthly sampling conducted by state drug officials.
Popular Drugs Fail Quality Checks
Among the drugs failing the quality check are common household names, such as:
- Paracetamol (IP 500 mg): A widely-used painkiller and fever reducer.
- Shelcal (Calcium & Vitamin D3 supplement): Popular for treating bone health issues.
- Pan D: An anti-acid medication.
- Vitamin C & D3 supplements: Frequently used for immune support.
- Glimepiride: An anti-diabetic drug.
- Telmisartan: Used for treating high blood pressure.
Several prominent pharmaceutical manufacturers, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Pure & Cure Healthcare, and Meg Lifesciences, were linked to the flagged drugs.
Spurious Medications Identified
The CDSCO report also pointed out spurious medicines, with a lab in Kolkata identifying antibiotics like Clavam 625 and anti-acid medication Pan D as such. These findings have raised concerns over counterfeit drugs entering the market, threatening patient safety. Cepodem XP 50 Dry Suspension, a common pediatric medication for infections, also failed quality tests.
Manufacturers’ Responses
In response to the findings, manufacturers of the flagged drugs provided explanations and denials. In one case, the manufacturer of the drug Pulmosil stated that the impugned batch was not manufactured by them and deemed it a spurious product. The company highlighted that further investigation would be needed to confirm this.
Public Health Risks
This development comes on the heels of the CDSCO’s earlier ban in August 2024 of over 156 fixed-dose drug combinations across India, citing “likely risk to humans.” The identification of such a large number of commonly used drugs as substandard could have far-reaching implications for public health, with doctors and pharmacists now on alert for alternative medications.
Authorities have urged patients currently using any of the flagged medications to consult with healthcare providers immediately. The regulatory body is intensifying investigations into these products to determine the root causes of the quality lapses and ensure accountability from the manufacturers involved.
Way Forward
The CDSCO is working closely with state drug regulators to tighten its surveillance on the production and distribution of pharmaceuticals, with additional measures being considered to prevent substandard and spurious drugs from reaching the market. Consumers are also encouraged to report any adverse effects or concerns regarding medications they use to help the CDSCO track any further irregularities.
