Last Updated on January 29, 2023 by The Health Master
Hyderabad, the fastest growing pharmaceutical and medical devices hub in the country, witnessed a two-day national level deliberation on the regulatory regime for medical devices in India, Medical Devices Rules 2017, and the role of regulatory officers in controlling medical instruments and apparatus, on July 2nd 3rd of 2022.
HODs of state drug control departments, directors of NIPERs, and the enforcement officers of the drug control departments of many states and union territories have assembled on a common platform to comprehensively think and ponder over ways to regulate, manufacture, distribution, supply, and sale of medical devices and to ensure availability of better medical equipment in the country.
The program was held on the campus premises of Gokaraju Rangaraju College of Pharmacy, Hyderabad.
The two-day mega event is organized with an intention to equip the regulatory officers of central and states to supervise and regulate medical devices.
Further, the program is intended to familiarize the enforcement officers with technical knowledge about the production process and the rules and regulations to comply with once the devices are on the market.
The conference is organized not by any industry body, but by the Telangana state branch of the Indian Pharmacy Graduates Association (IPGA) Telangana state branch in coordination with DCO India Drugs Control Forum, NIPER Hyderabad, and Pallavi Banoth Memorial Welfare Trust, Hyderabad.
Day 1
The day 1 program is inaugurated by Venkat Jasti, CEO & MD, Suven Pharmaceuticals, Hyderabad in the presence of:
- Dr. Atul Kumar Nasa, Drugs Controller of Delhi,
- Iarap. T.D.Toi, Drugs Controller of Meghalaya,
- C.S.Satheesh Kumar, Ex. Drugs Controller, Kerala,
- D.Hanumantha Rao, Ex.Drugs Controller of Andhra Pradesh,
- P.V.Appaji, Ex. Director-General-Pharmexil,
- Lalit Kr. Goel, Asst.Drugs Controller, FDA Haryana
- A. Mangakandan, IAS, Ex.Drugs Inspector, Tamilnadu and present CEO of Agra District Development Authority, U.P. and
- G.Koteshwar Rao, President, IPGA, Telangana and Chairman, Group Head- DCO India Drugs Control Forum & Pallavi Memorial Trust, Hyderabad.
Talking about the event, the Chairman of the organizing committee, G.Koteshwar Rao, who is also the president of the Telangana IPGA, said:
“There are differences in the regulation of medical devices and pharmaceuticals. The enforcement officers need to have technical knowledge about the production of devices and their full life-cycle”.
“The regulation of medical devices developed in India of late, so the regulators need to understand the regulatory regime in order to ensure the safety and effectiveness of the apparatus. Along with, they have to learn the medical devices rules 2017″, said G.Koteshwar Rao.
In his welcome speech G. Koteshwar Rao, expressed the need of a government testing laboratory for medical devices and to have a separate pharma university in Telangana and separate pharma Bhavan in Telangana to bring all associations like BDMA, IDMA, IPA, IPGA, APTI, etc.
Session I:
Session I is tarted with a talk by Dr. Shanti Moy Kar, Asst. Prof., Department of Medical Devices, NIPER, Hyderabad, and Dr.Sandeep Kumar, Depot. Of Regulatory affairs, NIPER.
Session II:
Session II is inaugurated and the dignitaries on the dais congratulated G Koteshwar Rao for making the event a grand success. Chief Guest Venkat Jasti, CEO, Suven Pharmaceuticals expressed that continuous education is required at all stages of any profession.
A cash reward of Rs. One Lakh and certificate and memento have been awarded to Best Drugs Control Officer in India to Amit Kumar Bansal, Drugs Control Officers, Varanasi, Uttar Pradesh by Pallavi Banoth Memorial Trust, Hyderabad chairman G.Koteshwar Rao. A cash reward of Rs. 10,000 was awarded to the best student from Gokaraju Rangaraju College of Pharmacy, Kotha Niharika Reddy by Pallavi Banoth memorial trust.
Session III:
Dr. Srikanth Nama, CEO, Rescisco Global Regulatory Consultants, Hyderabad has delivered a keynote speech on Medical Devices Regulations in India, an overview.
Session IV:
Dr. Shubhadeep Sinha, Senior Vice President, M/s Hetero Pharma delivered a speech on Clinical development and regulatory considerations of medical and biotech products during covid 19
Session V:
Dr. B. Dinesh Kumar, Ex Scientist G-ICMR-NIN, Hyderabad has delivered a speech on GXP- Regulatory Compliance.
Session VI:
Pallavi Banoth’s memorial lecture was delivered by Sumati Randeo, Director, Govt. Affairs, Danaher-India on Clinical Investigation of Medical Devices as per MDR 2017.
Session VI:
Prof. Dr. V. Prabhaker Reddy, HOD, Palamuru university college of pharmaceutical sciences delivered a speech on medical device policy in India.
Session VIII:
A. Mangakandan, IAS, (Ex Drugs Inspector, Tamilnadu), Distt. Development Authority, Agra has given a motivational speech on how to get through civil service examinations.
Day one session ended by 6.00 PM and the organizers arranged accommodation and food for all the 300 delegates who attended.
Delegates from Arunachal Pradesh, Assam, Bihar, Chattisgarh, Delhi, Goa, Gujarath, Hariyana, Jammu& Kashmir, Jharkhand, Sikkim, Rajasthan, Mizoram, Meghalaya, Tamilnadu, Karnataka, Kerala, Tripura, Uttarakhand, Uttar Pradesh, West Bengal, Telangana, Andhra Pradesh attended the symposium and expressed their overall satisfaction on the event conducted.
All the delegates were given participation certificates, mementos, and kits containing study material on medical devices.
The organizers have decided to conduct such an event next year July 1st & 2nd of the year 2023 at the national capital of Delhi with a minimum of 500 delegates. Day one ended with group photos and the national anthem.
Day 2 ended with industrial visits to selected medical devices manufacturing units in Medical devices park, Sultanpur, Hyderabad.
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