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Source: This post is created based on the article “How India’s drug regulatory regime can ensure greater credibility for our pharma industry” published in Indian Express on 18th May 2023.
Syllabus Topic: GS Paper 2 – Government policies and interventions for development in various sectors
Context: In the absence of effective regulations of pharmaceuticals industry, many casualties have taken place due to consumption of faulty medicines.
In January 2020, 12 children in Jammu died after consuming contaminated medicine manufactured by Digital Vision.
6 months later, a two-year-old from Himachal Pradesh died after consuming Cofset cough syrup, manufactured from the same company.
What are the issues associated with regulating pharmaceutical industry?
India has 36 drug regulatory bodies; however, an alarming number of drugs have recently failed to meet quality standards. For example, in February 2021, Global Pharma Healthcare had to recall a batch of eye drops exported to the US due to links with vision loss. Indian manufactured cough syrups caused many deaths in Gambia and Uzbekistan in 2022
Between November 2019 and November 2022, the US FDA raised 60 Official Action Indications (OAIs) against Indian pharmaceutical companies. It was found that procedures to prevent microbiological contamination of drugs were not established or followed. Also, environmental monitoring programmes do not include measures to control fungal contamination.
Some of these actions led to import alerts preventing them from supplying to the US market. These compliance failures can jeopardize India’s reputation as a reliable drug manufacturing nation.
3 per cent of all drugs in routine use — for hypertension, allergies and bacterial infections — were found to be substandard by regulatory inspectors.
What steps can be taken by government?
Despite the negative publicity, several countries still seek access to Indian generics. Therefore, the Indian pharmaceutical industry must take up the challenge and strive for zero defects in its products.
First, the Drugs and Cosmetics Act (1940) should be amended, and a centralised drug database should be created for effective surveillance of all pharmaceutical manufacturers.
Second, India’s 36 regional regulators should be merged into a single body.
Third, setting common standards across states could help reduce the risk of inconsistent regulatory enforcement.
Fourth, India has more than 10000 pharmaceutical manufacturing units. To cover all, additional budgetary support is needed to enhance inspection teams and enable more frequent quality-related inspections.
Fifth, increased transparency and credibility is required by public access to detailed notes of drug application reviews, past violations, inspection records, and failure history.
Sixth, there should be clear penalties for firms exporting spurious drugs, a public database of safety data, and a national law on drug recall.
Seventh, the Central Drugs Standard Control Organisation (CDSCO) needs to be reinforced with statutory backing and should be independent.
