The Indian pharmaceutical industry faces a number of quality concerns, including:?
- Compliance issues- The industry has 36 different regulators, which can lead to unscrupulous operators taking advantage of the most pliable jurisdictions
- Lack of infrastructure-The government lacks the infrastructure to ensure the quality of exported drugs. There are only 29 federal government drug testing laboratories and eight state-established laboratories.
- Fake medicines-Fake medicines can easily enter both domestic and overseas markets
- Substandard drug In 2021–2022, more than 2,500 of the drug samples examined by Indian states and territories failed to meet quality criteria, As per latest report of (CDSCO) The Central Drugs Standards Control Organization Video Link August alert CDSCO flagged 53 drugs, including Paracetamol and Pan D, as 'not of standard quality' (NSQ), raising significant safety concerns regarding their consumption
- Safety concern The industry's reputation has been damaged by escalating compliance issues that raise questions about the safety of pharmaceutical products.
- Global implications-The United States Food and Drug Administration (FDA) and other global regulatory entities have flagged a substantial number of non-compliant sites
In response to these issues, the Indian government has taken action, including:?
- Canceling the licenses of 18 pharmaceutical companies for manufacturing substandard quality drugs?
- Suspending the licenses of other companies or putting them on notice for quality issues?
- Announcing a $79.6 million investment to bolster the drug regulation system?
- Making it mandatory for cough syrup manufacturers to provide samples of their products for testing before export