A meeting of all state drug controllers has been called by CDSCO in Delhi on October 16 in the wake of repeated adverse reports of manufacturing facilities of Indian pharmaceutical companies by international regulatory agencies. Such reports are causing doubts about standards followed by Indian companies in the international market. CDSCO, therefore, is in the process of examining this issue  as a part of India's commitment towards compliance with global WHO- GMP norms.

This comes close on the heels of around 10 such cases of global scrutiny done on Indian drug makers by international regulators this year. "Our aim is to supply safe and efficacious medicines to other countries for the sake of patient safety. Process of adopting and learning WHO-GMP standards is a dynamic process and learnings from global regulatory counterparts on continuing good manufacturing practices will help manufacturers in adopting global practices followed in other countries where our medicines are consumed," explained Drug Controller General of India Dr G N Singh.

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.

Several Indian drug makers have come under the scanner of the US Food and Drug Administration (FDA) in recent years over a range of issues, including production quality, sanitation standards and alleged data manipulation. Ranbaxy was one of the companies that came under US regulatory heat as it had products from the company’s facilities in Toansa, Paonta Sahib, Dewas and Mohali in India barred. Generic giant Sun Pharma also came under fire after a US FDA ban on its plant at Karkhadi in Gujarat.

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.

Aimed at strengthening the regulatory mechanism, health ministry has also concluded a survey recently to test 43,000 drug samples from across the country, a process that started in April this year. The idea is to get more clarity on the percentage of spurious or low-quality drugs circulated in India.