In order to ensure audit-readiness of Indian manufacturing plants through a robust drug regulatory mechanism in the country, Central Drugs Standard Control Organisation (CDSCO) 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.

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.

Said Dr G N Singh, Drug Controller General of India (DCGI), “Our drug regulatory system is equipped to satisfy any kind of global regulatory scrutiny as not much of gaps have been found based on our independent critical gap analysis. We have also finalised a check list for the state drug regulators to ensure that there is uniformity of inspections across all the schedule M units in the country.”

Aimed at strengthening the regulatory mechanism, health ministry had also concluded a survey recently to test 47,000 drug samples from across the country, a process that started in April this year. Purpose of the survey is to get more clarity on the percentage of spurious or low-quality drugs circulated in India. Besides that GMP compliance is at the core of the government's consideration to supply safe and efficacious medicines to other countries for the sake of patient safety.

“Learnings from global regulatory counterparts on current good manufacturing practices (cGMP) will help manufacturers in adopting global GMP practices. Process of adopting and learning WHO-GMP standards is a dynamic process and followed in other countries where our medicines are consumed," explained Dr Singh.

US and European Union sanctions have hurt India’s image as an inexpensive and reliable supplier of generic drugs in international markets. India’s pharmaceutical exports totalled about $15.3 billion in 2014-15, marginally up from the previous year’s $14.84 billion.

As per the WHO website, GMPs includes 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.

CDSCO had conducted 17 training programmes to train drug inspectors on carrying out GMP inspections in the year 2013-14 to ensure quality of drugs supplied to over 200 countries from India.