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Gujarat FDCA signs MoU with NIPER Ahmedabad for training and capacity building of state drug controllers
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Shardul Nautiyal, Mumbai
February 22 , 2023
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The Gujarat Food and Drug Control Administration (FDCA ) has signed an MoU with National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad for knowledge sharing, training and capacity building of state drug controllers.
The capacity building program for drug regulators: a step towards continual learning training program for drug regulators of Gujarat FDCA is jointly organized by NIPER-Ahmedabad and National Forensic Sciences University (NFSU), Gandhinagar, Gujarat.
This will give a competitive edge to the state drug controllers (SDCs) in terms of doing the US FDA aligned audits in the Indian pharmaceutical industry in a timely manner for trust and compliance building with the manufacturers for safe and efficacious medicines.
Dr Rajiv Singh Raghuvanshi , secretary-cum-scientific director, Indian Pharmacopoeia Commission (IPC) was also present during the MoU signing as the chief guest along with guest of honour Manoj Aggarwal, additional chief secretary, department of health & family welfare, and Gujarat. Prof (Dr) Shailendra Saraf, director, NIPER Ahmedabad gave the welcome speech.
Inaugural lecture was given by chief guest Dr Rajeev Raghuvanshi, secretary cum scientific director, IPC. Subjects covered were changes in upcoming Drug and Cosmetic Act/Bill, counterfeit and adulteration in drug supply, regulation and quality control of blood and related products and medical device regulation. There were also brainstorming, experience sharing and co-learning sessions.
“The training programme will give the relevant exposure to the state drug control officers to meet the compliance requirements of all the stakeholders and help maintain the credibility of Gujarat as a role model for other states in terms of good governance and monitoring of spurious medicines. Gujarat FDCA has achieved a milestone in terms of drawing over 15, 000 samples annually in two years in a row with only 2% samples having failed the quality tests,” informed Gujarat FDCA Commissioner Dr Hemant Koshia.
“Indian Pharmacopoeia (IP) is today evolving towards helping develop quality and safe medicines for export purposes towards maintaining India’s credibility as the Pharmacy of the World. The production linked incentive (PLI) scheme which has a list of 48 molecules will help India towards indigenous manufacturing. There are 4 companies from Gujarat which are a part of the PLI scheme. The bulk drugs park will also be a boon for making India self-reliant in bulk drugs,” Dr Koshia added.
Talking about vaccine development, Dr Koshia said, "Intranasal vaccine is a great example of India's innovation prowess in the vaccine development arena as it is based on novel drug delivery system (NDDS) and is done through nasal route. It is a painless approach and does not create bio-medical waste. It is easy to administer and builds up immune barriers in the respiratory tract through which respiratory viruses enter the body. On the contrary, injectable vaccines lead to cross-contamination as it is done through parenteral route.”
The nasal vaccine -BBV154 -branded as iNCOVACC had received approval of the Drugs Controller General of India (DCGI) in November, 2022 for restricted use in an emergency situation for those above 18 years as a heterologous booster dose.
Present on the occasion were Dr Ravi P Shah, HOD, pharma analysis, NIPER, Dr. Mahesh Chhabria, Dr J. B. Dave, Dr Viranchi Shah, National President, IDMA, Dr A Ramkishan, deputy drugs controller, CDSCO, Dr Shrinivas Savale, CEO, AIC LMCP, Dr Sudhir Shah, Padma Shri Awardee, Dr Akshay Srivastava, Gourang Oza, Sumati Randeo, director, Government Affairs, Omprakash Sadhwani, Ex-Joint Commissioner, Food and Drugs Administration (FDA), Maharashtra, Dr Prajesh Prajapati, Dr Nitish Sharma, Dr. Prof M Ghate, Dean, School of Pharmacy, NFSU, Sudhir Deshpande, Ex-Joint Commissioner, Food and Drugs Administration, Maharashtra, Dr Pinaki Sengupta, Dr Deep Pooja, Dr Dhara Patel and Dr Sangita Shah.
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