Last Updated on January 29, 2021 by The Health Master
The Gujarat Food and Drug Control Administration (FDCA) is in talks with Central Drugs Standards Control Organisation (CDSCO) and Indian Drug Manufacturers Association (IDMA) Gujarat chapter to give boost to Micro, Small and Medium Enterprises (MSMEs) through a series of upskilling and training programmes towards adherence and compliance to WHO-GMP standards.
Gujarat FDCA recently concluded a virtual meet with US FDA officials and shared experiences of the ongoing C-19 pandemic towards equipping Indian regulators and industry on Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Lab Practices (GLP).
According to Gujarat FDCA Commissioner Dr H G Koshia, “We are talking to IDMA and CDSCO Western Zone Deputy Director to start with one training programme towards orienting the MSMEs to upgrade themselves to WHO-GMP so that small pharma players get the advantage of the evolving global regulatory regime.”
The small and medium pharmaceutical companies had earlier urged the Centre to expedite implementation of Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) so that they can avail interest subsidy of 6% to upgrade infrastructure and technology to globally accepted standards.
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The aim of the scheme is to help pharma MSMEs improve technology and infrastructure to migrate from Schedule M to World Health Organisation good manufacturing practice (WHO-GMP) standards.
For this, the Centre has offered a 6% interest subvention on loan up to Rs. 8 to 10 crore for three years. It has earmarked Rs. 300 crore for disbursal as interest subsidy for 2020-2022.
According to experts, there is a need for risk based inspections and embracing global standards through upgradation of Schedule M units to WHO-GMP compliant units to retain India’s position as pharmacy of the world.
Gujarat has over 700 plus WHO-GMP units and 130 US FDA approved drug manufacturing units in the country. Gujarat also has the distinction of having 28 per cent of drug exports to developed markets including the US.
The state is aggressively moving towards upgradation of Schedule M units to WHO-GMP compliant drug manufacturing units as part of the global harmonization programme.
US FDA-Gujarat FDCA Regulatory Forum which was started in the year 2008 to usher in dialogue between senior leaderships of the USFDA and Gujarat FDCA to take forward the avenues for future strategic collaboration towards effective regulatory compliance has immensely helped Gujarat drug control officials in understanding regulatory requirements of USFDA.
US-based consulting firm World Compliance Seminars (WCS) in 2018 also conducted workshops on subjects like how to be prepared for USFDA inspections and how to develop quality culture in Indian pharma companies.
A team of USFDA officials last year visited Gujarat FDCA in which Letitia Robinson, country director, OIP, India Office, USFDA met Gujarat FDCA Commissioner Dr H G Koshia towards building regulatory compliance in both countries.
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