As per the new government notification released on Saturday, new manufacturing standards must be met by the Indian pharmaceutical companies this year. Citing the debt load, small companies have asked for a delay.
Action to Redress Overseas Deaths Linked to Indian-made Drugs
There has been a string of overseas deaths linked to Indian-made drugs since 2022 and in order to combat the same the Modi government has stepped in the scrutinize the Indian pharma companies in order to clean the blemish on the image of the $50 billion industry.
As per the notification dated 28th Dec, 2023 “The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy”.
It says that only after getting the “satisfactory results” on tests of the ingredients and retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch should any company consider making and marketing it as a finished product.
Challenges faced by Indian Pharma Industry
In August last year, the health ministry revealed that post the inspections of 162 drug factories since December 2022, they found an “absence of testing of incoming raw materials”.
Also, they revealed that only approx 25% of India’s 8,500 small drug factories met international drug manufacturing standards set by the World Health Organization (WHO).
For the same, the notification has given a period of 6 months to large pharma drug makers and 12 months to small players.
However, citing reasons like debt load, the small companies have requested for the extension in the deadline, warning that investments required to meet the standards would shut down nearly half of them because they are already heavily indebted.
The WHO and other health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon.
