The Maharashtra Food and Drug Administration (FDA) has urged the Central Drug Standards Control Organisation (CDSCO) to consider industry’s plea towards easing out repeated joint inspections on same premises for loan licensing units in the country.

This comes at a time when the industry has provided a list of some APIs and intermediates that could be manufactured in India by developing processes with the help of various government labs and institutions. It was also suggested by the industry as to how CDSCO should simplify approval process for APIs and also provide short, medium and long term action plans.

Says Maharashtra FDA Commissioner Dr Pallavi Darade, “We have raised the industry’s concern towards repeated inspections of the same premises and CDSCO has very much acknowledged the plea. A positive response on the same is however awaited.”

With growing emphasis on boosting SMEs to help meet the regulatory requirements of not only India but also other major markets like US, Europe and Japan, there is an urgent need for the manufacturers who are revised schedule M compliant to upgrade to WHO GMP and those who are WHO GMP compliant to upgrade to USFDA or EDQM compliance.

Industry believes that Indian SMEs should work in unison to ensure that “Made in India” becomes a brand synonymous with pharmaceutical products globally.

India continues to be heavily dependent on China for import of APIs and intermediates. There was a period of a few months of tension last year due to the standoff with China on border issues. This led government and industry to plan for an eventuality of stoppage of supplies from China of APIs and intermediates.

Subsequent to this, Drug Controller General of India (DCGI) Dr G N Singh proactively called an industry meeting on 10 July 2017 to assess the preparedness of domestic API industry in such a scenario. He also provided a five-point agenda seeking views on how to plan for such emergency situations. Indian industry has also embraced global regulatory harmonisation process with DCGI allowing risk-based self-inspection of manufacturing units.

Till about a decade ago, China was trying to catch up with India in APIs. Today, with their Government’s unstinted support, they have moved far ahead and Indian pharmaceutical industry is trying to catch up with them. There is an urgent need for the government to support the industry with a conducive environment and policies. Submissions have been made to the government highlighting how API industry can recover and confidently move ahead to claim the rightful place as the source for quality APIs.

The Indian pharma companies have the skills and the ability to overcome challenges and thrive in the marketplace. The industry also understands and appreciates that regulations need to be respected and complied with to function effectively.

“We are working with the regulators in ensuring that our people and people globally have continuous access to ‘Made in India’ affordable quality medicines that will boost Indian pharmaceutical industry,” concluded a senior industry professional.