CDSCO looks to take more processes online

CDSCO looks to take more processes online

The Central Drugs Standard Control Organization (CDSCO), the agency responsible for approving new drugs, clinical trials and laying down standards for drugs, has decided to take more of its approval processes and procedures online. An initiative aimed at enhancing transparency and ease of doing business overthe next two years, it will pertain to productregistration, quality certification as also outcome of studies, Drug Controller General of India V.G. Somani said.

Except inspection, sampling and testing, the idea is to take most of the other processes online.“You can find [implementation] in one year itself. But it needs some time to validate [as] whenever you start any online system it depends on the IT service provider. There can be some hiccups, ” Mr.Somani told the media on the sidelines of the inauguration of two-day international regulators meet being organised here by the Pharmaceuticals Export Promotion Council of India (Pharmexcil). He added he wanted to see the Indian supplies from 40% (by volume) to 60% in three years. To queries on whetherIndian drug makers were subjected to more scrutiny by the US Food and Drug Administration and the regulatorred-flagging Valsartan, a drug indicated for blood pressure and heart failure, he said there was nothing wrong in that. “U.S. has complete right to do what they want to do, procure,reject and term it as a risk. It [however] does not mean that the same thing will be followed by EU, Japan and India. USFDA has always been keeping a very distinct image of itself… we are not any less stringent in any manner, ” he said. CDSCO was looking at the issues flagged by USFDA about Valsartan containing cancer inducing impurities.

“We are investigating and take appropriate decision whetherto accept it as a risk ortake some action on the prescribing information of that product or whetherto ban that product, ” he said. At the conference, the DCGI sought to underscore the significance of convergence among regulators, especially to avoid duplication ofregulatory processes, to improve affordability and accessibility of regulatory practices and get away from unnecessary red tape practices, ” he said.

Dinesh Dua, chairman, Pharmexcil, said, “Industry needs constant regulatory support to make medicines affordable and accessible. The industry should come out with a mechanism to identify the counterfeit manufacturers and help take action against him. MSMEs can start exploring to export their products to regulated markets to keep their operational costs low.”

With the support of Ministry of Commerce & Industry, Pharmexcil has organised an “International Regulators Meet” inviting Food & Drug Regulatory Officials from all regions, with a focus on the major export destinations to have wide networking and global outreach. The meet is aimed at “International Regulatory Convergence to Promote Accessibility and Affordability of Quality Medicines”.

Regulators from about 25 countries are participating in the International regulators meet including Brazil, Chile, Argentina, Colombia, CARICOM countries, Ukraine, Egypt, Iran, Nigeria, Cote d-Ivorie, Ghana, Zambia, Ethiopia, Rawanda, China, Vietnam, Nepal, Myanmar, Indonesia & Bangladesh etc. DCGI along with CDSCO senior officials and State drugs controllers are joining this conference to have deliberations with overseas regulators on harmonisation of regulations.

Udaya Bhaskar, director general, Pharmexcil, said, “In July 2019, Indian exports have already recorded a 21.7 per cent growth with $1.7 billion exports. The cumulative growth of Indian exports for the period of April-July 2019 is 13 per cent. We are expecting to touch $21-$22 billion exports in the fiscal year 2019-20.”

[Courtesy: https://telanganatoday.com/drugs-regulator-to-improve-transparency | https://www.thehindu.com/business/cdsco-looks-to-take-more-processes-online/article29461544.ece ]