Rampant fakes of lifesaving drugs found in Delhi, Jharkhand | 24 June, 2024

India’s apex drug regulator has warned consumers about spurious copies of five potentially lifesaving medicines being sold in the market, as well as 50 other drugs that it said were not of standard quality. The Central Drugs Standard Control Organization heightened inspections in the domestic pharmaceutical market after India-made cough syrups were linked to the deaths of children in Uzbekistan and Gambia. Following recent inspections, drug authorities found 12 outlets in New Delhi involved in the distribution of spurious drugs, including one at Bhagirath Place, a wholesale market distributing medicines across India.

Increased risk of morbidity
CDSCO, in its alert for April, reported finding spurious versions of these five drugs in the market:

• Anti-HIV medication Dolutegravir tablets IP 50 mg
• Telmisartan 40mg and Amlodipine 5mg tablets IP used for the management of high blood pressure
• Domperidone and Naproxen Sodium tablets, used to manage migraines and pain
• Rifaximin tablets, used for treating diarrhoea and liver disease
• Cefixime Trihydrate with Lactic Acid Bacillus tablets LP, used to treat bacterial infections

“‘Not of standard quality’ and spurious drugs can cause treatment failure and adverse reactions, increase the risk of morbidity and mortality, and lead to drug resistance,” said a state drug controller, requesting anonymity. “Poor-quality medicines also increase healthcare costs to patients and the health system, wasting resources that could otherwise be used to benefit public health.”

A central database
Drugs Controller General of India, Rajeev Raghuvanshi, on 9 February directed state drug licensing authorities to routinely analyse drug samples and keep a strong vigil on medicines available in the market. Following inspections, state drug authorities verify samples with the manufacturer to confirm the authenticity of the medicines. Information from the state authorities are logged in a centralised monthly database of spurious and medicines deemed ‘not of standard quality’.

“Prior to this, there was no centralised database of sale outlets where NSQ/spurious products were reported. Such identified outlets are to be kept for regular vigilance” said the state drug controller quoted earlier. “Whenever a drug inspector collects the samples, he checks the quality and efficacy of drugs and cosmetics available in the market with their approved specifications,” the official said. “This process involves monitoring the quality of the (active pharmaceutical ingredients), excipients, and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorised shelflife.”

The CDSCO in its latest communication said the state drugs licensing authorities of Mizoram, Tripura, and Pondicherry had reported nil findings of spurious drugs in April. However, most other states, including Andhra Pradesh, Bihar, Gujarat, Maharashtra, Tamil Nadu, and West Bengal, have not submitted their findings.

(Source: Mint)