In lines with strengthening the cooperation between the CDSCO and the US FDA, team of top delegates from the US drug regulatory authority headed by Howard Sklamberg US FDA’s deputy commissioner for global regulatory operations and policy recently had a meeting with the Indian regulatory counterparts in Delhi. This move comes in continuation to the letter of intent signed between drug controller general of India (DCGI) Dr G N Singh and US FDA commissioner Margaret Hamburg in Delhi last year to beef up regulatory apparatus.
The main aim behind this meeting was to understand the regulatory mechanism in the country and sensitise the Indian regulators and the industry about the regulatory requirements and the expectations of the US FDA. Interestingly, this visit also highlights the growing importance of India in the US, as a major supplier of high quality affordable generic drugs.
According to Dr S Eswara Reddy deputy drugs controller of India CDSCO, Ahmedabad the US FDA officials have shown keen interest in working with the CDSCO on many levels including conducting joint inspection, exchange programmes, especially training and data sharing activities that will help in ensuring better healthcare and efficient patient services to all. Most importantly, he added that the meeting set ground to create a platform that will enable easy access for the regulators to interact with key stakeholders to address regulatory issues more efficiently and effectively.
Their visit is also targeted to understand what challenges the Indian government is facing with regard to drug and food safety and also hear from both American companies operating in India, as well as Indian manufacturers on their issues.
Dr H G Koshia, commisoner of Gujarat FDCA who was one among the other four select state drug regulators to be in the meeting with the US FDA officials pointed out that the growing interest of the US regulatory body shows their keen interest in working with the Indian counterparts at greater level. A recognition that can help in further bolstering the exports to the US, he added.
“This is a win-win situation for all, as synergizing our strength for strengthening the regulatory apparatus further through a uniform mechanism will enable and benefit patients across US and India. There is no denying the fact that Indian companies play a major role in supplying affordable generic drugs to the US. In fact it is important to note that exports of pharma products to the US has increased by 65 per cent in the last five years, a tremendous rise which is acknowledged by the US FDA,” Dr Koshia informed.
The other drug controllers were from Andhra Pradesh, Himachal Pradesh, Odisha and Madhya Pradesh. The US FDA officials later also met key stakeholders and associations as well to get a know how about their issues and challenges. It is understood that following the same, they also visited the manufacturing facility of Glenmark in Goa today.