Against the backdrop of growing global scrutiny from international regulators in the past five years on drug quality, Central Drugs Standard Control Organisation (CDSCO) plans to increase audits in the manufacturing units across the country towards compliance to Good Manufacturing Practices (GMP) as per the requirements of the respective markets globally.
Says a senior CDSCO official, "Any product which does not comply with good manufacturing practices of overseas markets is being considered as adulterated and hence faces the chance of losing the market. The surprise audits will help streamline the objective of meeting the GMP requirements of respective countries where the drug is exported."
This is also in line with CDSCO's plans to bring about uniformity in inspections of Schedule M units across the country as a part of its programme to upgrade Schedule M units to WHO-GMP level. A check list has also been finalised for the state drug regulators to ensure that there is uniformity of inspections across all the Schedule M units in the country.
This will be a big boost to several Indian drug makers which had come under the scanner of the global drug regulatory authorities in the recent years over a range of issues like data integrity, including production quality, sanitation standards and alleged data manipulation.
The current upgradation of WHO-GMP norms 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," explained a CDSCO official.
Global GMP violations have hurt India’s image as an inexpensive and reliable supplier of generic drugs in international markets. India’s pharmaceutical exports totalled about US $15.3 billion in 2014-15, marginally up from the previous year’s $14.84 billion.
As per the WHO website, GMPs include 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 personal hygiene.
Growing number of audits are going to be taken up by global counterparts worldwide in the future with global regulators hiring drug inspectors for auditing sites in respective countries of engagement and operations for GMP compliance.
Approximately 1400 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 approved manufacturing facilities outside the US.