CDSCO looks to take more processes online

Aims to boost ease of doing business

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 over the next two years, it will pertain to product registration, quality certification as also outcome of studies, Drug Controller General of India V.G. Somani said.

“They are partly available presently. [From] processing of applications, interactions with manufacturers or distributors [everything] will be online,” he 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 pharma industry increase its share in global drug supplies from 40% (by volume) to 60% in three years.

To queries on whether Indian drug makers were subjected to more scrutiny by the US Food and Drug Administration and the regulator red-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 whether to accept it as a risk or take some action on the prescribing information of that product or whether to ban that product,” he said.

At the conference, the DCGI sought to underscore the significance of convergence among regulators, especially to avoid duplication of regulatory processes, to improve affordability and accessibility of medicines. In doing so, “each should follow good regulatory practices and get away from unnecessary red tape practices,” he said.

Regulators from 25 countries are participating in the conference, whose inaugural session was addressed by Pharmexcil chairman Dinesh Dua and director general Ravi Uday Bhaskar.

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