Taking forward the government’s mandate for upgradation of Schedule M units to WHO-GMP level towards good manufacturing practices adopted globally, Gujarat Food and Drug Control Administration (FDCA) has witnessed more than 10 per cent increase in the WHO-GMP units in the past one year in the state complemented with growth in pharma exports.
Accounting for 28 per cent of pharma exports, state of Gujarat has also registered a growth of 445 per cent in pharma exports in the past one decade. Exports worth 3,060 million US dollars has been achieved in 2016 from Gujarat in comparison to exports worth 562 million US dollars in 2006.
Says Dr HG Koshia, Gujarat FDCA Commissioner, “Schedule M units are consistently on an upgradation mode with the current global harmonization trends on good manufacturing practices (GMPs) with more than 10 per cent increase in the past one year. As older ones get upgraded, the numbers go on increasing and as of today, the state boasts of more than 400 WHO-GMP accredited units and nearly all foreign accredited units.”
Gujarat has 255 WHO certified manufacturing units with 23 MHRA certified, 24 TGA certified, 15 EU certified and 16 PICS certified. Besides this, it boasts of 158 formulation units and 97 bulk drug units. It has 40 per cent of CROs and 40 per cent of CRAMS companies.”
Over 3,300 manufacturing units are located across the state in four large clusters with 5 special economic zones in an area of over 1,500 hectares.
Meanwhile, the Drug Controller General of India (DCGI) has submitted a proposal to the Union health ministry to mandate upgradation of Schedule M units across the country to WHO-GMP level.
The Union health ministry is also planning to frame and release a draft guideline towards constant upgradation of good manufacturing practices (GMP) to align India-specific standards with global regulations.
The current upgradation to WHO-GMP level is being evolved around the learning from global regulatory counterparts on current good manufacturing practices (cGMP) which will help manufacturers in adopting global GMP practices.
Approximately 1,400 manufacturing units in India are WHO GMP certified, and over 800 are UK MHRA approved. India continues to have the highest number of US FDA registered manufacturing facilities outside the US. The industry has strong capabilities in product development. Also, Indian pharmaceutical companies have the largest share of DMFs and ANDAs outside the U S.
GMPs is based on a criteria involving factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personnel. Global GMP violations have hurt India’s image as an inexpensive and reliable supplier of generic drugs in international markets.