Recent quality tests conducted by India’s drug regulatory agency have revealed alarming failures in several widely-used medications, prompting concerns about patient safety and public health. The Central Drugs Standards Control Organisation (CDSCO) issued a “Not of Standard Quality (NSQ)” alert for August, highlighting over 50 drugs, including well-known treatments for hypertension, diabetes, and stomach infections.
List of Drugs Failing Quality Tests
Among the flagged drugs are:
- Pan D: An antacid used for gastrointestinal issues.
- Shelcal: A calcium supplement.
- Glimepiride: An anti-diabetic medication.
- Telmisartan: A high blood pressure drug.
Doctors have raised concerns that patients may require additional doses due to the substandard quality of these medications, potentially prolonging treatment and increasing healthcare costs.
Manufacturers Deny Responsibility
Notable pharma companies, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics & Pharmaceuticals Ltd, are involved in the NSQ alert. However, these manufacturers have indicated that the flagged batches are spurious and not produced by them.
Multiple batches of Telmisartan manufactured by Life Max Cancer Laboratories, as well as Metronidazole from HAL, have been found lacking quality. Similarly, Alkem Health Science’s Clavam 625 and the antacid Pan D were identified as spurious by a drug-testing laboratory in Kolkata. Other drugs from Hetero, including Cepodem XP 50, used for treating severe bacterial infections, have also been implicated.
Industry Responses to the Alert
Spokespersons from Alkem and Sun Pharma have both emphasized that the products listed are not manufactured by their companies and are, therefore, spurious. They stated that they are engaging with the authorities to clarify the situation. The CDSCO’s alert included responses from these manufacturers, reiterating that the drugs in question do not originate from their facilities.
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Potential Impact on Public Health
Health experts are expressing deep concern over the implications of these quality failures. Dr. Sumit Ray, medical director at Holy Family Hospital, stated, “It is not good news for doctors, patients, and the country as a whole.” He noted that poor-quality medications could lead to inadequate recovery and increased healthcare expenses, as patients may require longer treatments and multiple visits to doctors.
The risk of antimicrobial resistance (AMR) is also a significant concern, especially as substandard antibiotics contribute to this growing issue in India.
International Repercussions and Concerns
The recent trend in drug quality failures poses not only a domestic challenge but also threatens India’s reputation on the global stage. Since October 2022, India has faced accusations of exporting low-quality medicines to several countries, including The Gambia, Uzbekistan, and the United States. These allegations have cast a shadow over India’s drug regulatory agency, the CDSCO, and threaten the country’s status as a leading pharmaceutical hub.
As the situation develops, the Indian public and healthcare professionals await further clarity from regulatory bodies and the implicated pharmaceutical companies.