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| Product Responsibility |
| REGULATORY COMPLIANCE |
| Achieving and maintaining regulatory compliance efficiently is vital for a pharmaceutical company to remain operational and competitive. |
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Over and above institutionalising systems and audits to achieve, maintain and improve regulatory compliance, our focus has always been on developing and nurturing an innate GMP culture across the organisation. |
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| Our constant effort is to eliminate irrational processes and, through training and leadership, instil sustainable processes into the psyche of every individual within our sphere of operation. |
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| Our constant effort is to eliminate irrational processes and, through training and leadership, instil sustainable processes into the psyche of every individual within our sphere of operation. |
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| Our compliance levels have increased significantly and so has our engagement with the regulatory bodies. In the pharmaceutical sector, the demands of compliance are very high. Our regulation and compliance department makes periodic visits to the offices of the regulator and actively engages them in order to seek their advice on major issues relevant to Dr. Reddy's and to stay updated on the compliance front. |
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| This enhanced engagement has also helped us understand how the regulators interpret compliance criteria and has thereby helped us contain the risk of misinterpretation. Based on this knowledge we have recalibrated our systems and processes. |
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| We are always eager to share our best practices with our peers. We are transparent and have no reservation in showing our facilities and labs for the greater good. |
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| We are always audit-ready. When audits are scheduled we don't make any special preparations. Compliance is our daily regimen; it is in our DNA. |
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| In the reporting period, two of our formulation plants, Hyderabad and Vishakapatnam, were audited by the USFDA and were certified to be producing medicines according to the highest international standards. Our formulation plant at Vishakapatnam was also audited and certified by BrazilΡtional Health Surveillance Agency (ANVISA). In addition, our chemical plants were audited and certified by the United Kingdomͥdicines and Health products Regulatory Agency (MHRA). These successful audits, conducted in line with some of the most stringent auditing procedures, give us and our customers the reassurance that we are doing what we are meant to do ಯviding safe, efficacious, affordable and innovative medicines for healthier lives. |
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To comply with global regulatory requirements that ensure product quality and safety requirements as laid down by key governing bodies, namely FDA and MHRA, we follow the ICHQ7 guidance document for API, 21 CFR Part 210 and 211 for Formulations, applicable European regulations and Indian Drugs and Cosmetic rules. |
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| In our PSAI (Pharmaceutical Services & Active Ingredients) segment, we have eight USFDA inspected facilities (six in India, one in Mexico and one in the UK). In our Global Generics segment, we have two USFDA inspected plants (one in India and one in the US). Each facility in India has been audited and certified by an Indian regulatory authority. In addition, our facilities are inspected by the USFDA to assess compliance with current Good Manufacturing Practice regulations (cGMP). |
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| Furthermore, the Ministries of Health of Brazil (ANVISA), Ukraine, Romania, TGA, Danish Medicines Agency and World Health Organisation have visited us and approved our facilities. |
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Manufacturing
Facility* |
Regulatory
Certifications |
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FTO1 |
WHO, ANVISA, Romania, Ukraine, Uganda, GCC |
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FTO2 |
WHO, MHRA, Ukraine, Romania, ANVISA , Uganda, MCC |
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FTO3 |
WHO, FDA, MHRA, ANVISA, TGA, Romania, MCC
Danish Medicines Agency, Ukraine , Uganda, Turkey
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FTO4 |
WHO |
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FTO6 |
WHO |
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FTO7 |
WHO , USFDA, BfARM |
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CTO1 |
WHO, FDA, Danish Medicines Agency, Korea FDA |
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CTO2 |
WHO, FDA, Danish Medicines Agency, Korea FDA |
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CTO3 |
WHO, FDA, Danish Medicines Agency, Korea FDA |
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CTO4 |
WHO, FDA, Danish Medicines Agency, Korea FDA |
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CTO5 |
WHO, FDA, Danish Medicines Agency, Korea FDA |
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CTO6 |
WHO, FDA, Danish Medicines Agency, Korea FDA, TGA, PMDA |
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| *All the above are India based manufacturing facilities |
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| Apart from regulatory audits, customers too conduct audits across our units. During these audits, we receive valuable feedback and observations and we work towards incorporating them into our quality system. |
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| "We work around a singular philosophy - Are our customers delighted? For us at
the regulation and compliance department, our customers are the regulatory bodies." |
- Zohar Shihorwala,
(Vice President, Global Regulatory Affairs) |
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