Several batches of generic medicines being sold at Jan Aushadi Kendras, some 632 in Karnataka, and more pan-India have been recalled after failing standard quality tests of state drug controller, calling into question if these affordable medicines are putting patients' lives at risk.
The Bureau of Pharma PSUs of India (BPPI) that runs Jan Aushadi Kendras across the country has recalled 106 batches of 52 drugs over the past four years.
These include common medicines like Telmisartan and Ramipril used to treat high blood pressure, Nimesulide, a pain medication with fever-reducing properties, and even Calamine lotion, used to treat mild itchiness. While the average MRP of Telmisartan 20 mg tablets sold by the top three leading brands is Rs 33.80, the BPPI MRP is Rs 6.73. Other tablets cost less than half the market price as well.
| Drug | BPPI MRP | Average MRP of top three leading brands |
| Ramipril | Rs 9.10 | Rs 113.36 |
| Nimesulide | Rs 12.42 | Rs 73.63 |
| Calamine lotion | Rs 19.52 | Rs 102.00 |
A former employee of BPPI told DH, "Fifty percent of the sales of generic medicines come from the five southern states. In 2019, out of sales worth Rs 310 crore Karnataka, Kerala, Tamil Nadu, Andhra Pradesh and Telangana alone accounted for Rs 149 crore. After Uttar Pradesh, it is Karnataka that has one of the highest Kendras but they are being dumped with short shelf-life drugs from private manufacturers and substandard drugs."
"Many of these drugs have not only reached the stores but were also sold causing an allergic reaction in patients. For example, a Kendra owner in Bengaluru, demanded a quality check report of a calcium tablet's batch after the patient, a young boy's tongue turned blue," he told DH showing the drug code and batch number. DH reviewed the picture of the child showing his discoloured tongue.
The Karnataka Whatsapp group of Jan Aushadhi Kendra owners is flooded with frequent complaints of not-of-standard-quality (NSQ) drugs and shortage of supply complaints. "Many of these drugs have a shelf-life of less than three months," he said.
| Year | No. of drugs recalled | No. of batches recalled |
| 2016-17 | 8 | 8 |
| 2017-18 | 21 | 31 |
| 2018-19 | 19 | 40 |
| 2019-20 | 4 | 27 |
Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes and runny nose. Five batches of it were recalled in October last year just two months before its expiry. It was manufactured in February 2018. Dhiraj Sharma, General Manager, Marketing & Sales, BPPI, said that while in the pharma industry the average sample failure rate was 2%, its average failure is 0.44%, out of 7,184 batches purchased in 2019-20.