BPPI finding 25 batches of drugs entering Jan Aushadhi to be substandard

The Jan Aushadhi scheme aims to make generic drugs affordable to the poor. While BPPI has promised strict action against the companies—from banning the sale of the respective batches to blacklisting them, one of the 18 is a PSU.

The FDA issued Form 483 with 10 observations to Aurobindo Pharma on the plant which was audited by the US drug regulator between May 13 and May 24.

The Bureau of Pharma PSUs of India (BPPI) has found 25 batches of drugs by 18 pharmaceutical manufacturing companies, supplied to Jan Aushadhi outlets from January 2018, to be substandard. The Jan Aushadhi scheme aims to make generic drugs affordable to the poor. While BPPI has promised strict action against the companies—from banning the sale of the respective batches to blacklisting them, one of the 18 is a PSU. A state-owned company being counted as an offender, along with the fact that there have been 18 recalls in the past two years, points at a larger problem—the country is unable to enforce strict quality control and drug standards regulation. Holes in the Central Drugs Standard Control Organisation net and lack of deterrence from BPPI’s quality control let spurious, substandard drugs hit the market, with no accountability for failures in the processes of procurement under Jan Aushadhi.

Drug stability requirements vis-à-vis wide availability of cheap generics must be addressed. In India, the stability test is mandatory only for “new drugs”—after four years of the drug’s existence in the market, it is not required. In 2017, Drug Controller General of India had issued an order whereby manufacturing companies were ‘advised’ to submit their stability testing. Stability testing is one of the most important aspects of quality testing and it is indeed shocking that the highest drug regulatory authority of the country is not seeking to make it mandatory.

This article was first uploaded on June nineteen, twenty nineteen, at fifty-six minutes past two in the night.