Indian Pharma companies on US FDA lens

Why are so many Indian Pharma companies failing on Data and Quality standards and getting warnings that can lead to 483? Currently, 40+ Indian manufacturing sites are listed on FDA’s import alert list..

Global Supply-Demand issues: Indian Pharma is a major supplier of Generics to the world. If shun atleast 2/3 of the world runs a risk of demand-supply gap in Generics. Hence it is in the interest of UN, WHO and Developed Economies to help Indian Pharma climb the FDA compliance.

Cultural Issues: Traditionally Indian Pharma industries lack respect for Data and Quality paradigm. IT and Quality are the least paid and lowest in Hierarchy. Compare it to the Global Pharma MNCs where the IT and Quality hold Director or C-level positions.

Regulatory Issues: Highlighting weak regulation and monitoring of the domestic drug industry, three recently-introduced medicines are being prescribed and sold though there is a lack of rigorous trials on crucial safety and efficacy parameters. The pharmaceutical industry in India should face the same stringent regulations as elsewhere in the world, rather than continuing to allow patient safety to be put at risk by unproven drug treatments, says an article published in TOI. The Quality issues arise because Pharma Industry is under Ministry of Chemicals not under Ministry of Health @MoHFW_INDIA. This is a huge accountability gap in India. It will be in the interest of Public Health agencies like WHO and Global Fund and Global Pharma MNCs to demand the Dept of Pharmaceuticals to be located under the Ministry of Health with proper accountability established.

Data Reliability: Majority of the FDA observations are for relatively commonplace documentation or procedural issues...so many of the observations are for egregious errors like altering official documents in front of an inspector, or documenting important manufacturing or electrical data on scrap paper in pencil. Manipulated clinical trials data. “Generic” user accounts had been created in the Laboratory Information Management software system.

QA/QC Issues: Manager has admin rights on the software to edit or overwrite the data. Fudging of attendance records such as same employee working in 2 different sites at the same time. Even unauthorized QA document control stamps are reported. 

Other issues: Partially completed and/or unofficial training records. No response to consumer complaints. Incident reporting cover ups. 

References:

• FDA Form 483s From India: A Deep Dive Into the Problems: http://www.raps.org/Regulatory-Focus/News/2015/11/09/23562/FDA-Form-483s-From-India-A-Deep-Dive-Into-the-Problems/#sthash.bMMKjjGv.dpuf
• The Rs1 trillion FDA impact on Indian pharma: http://www.livemint.com/Companies/zcSsHW6iNvlulIW5K1qk9N/The-Rs1-trillion-FDA-impact-on-Indian-pharma.html
• Cadila Healthcare shares slump 15% on warning letter from USFDA http://www.financialexpress.com/article/markets/indian-markets/cadila-healthcare-shares-slump-over-15-on-warning-letter-from-usfda-december-31-2015/185907/
• Indians face risk from unproven drugs: Lancet http://timesofindia.indiatimes.com/india/Indians-face-risk-from-unproven-drugs-Lancet/articleshow/49029617.cms