DCGI to unveil CDSCO’s Vision 2020 at 60th IPC

DCGI to unveil CDSCO’s Vision 2020 at 60th IPC

Viveka Roychowdhury

(R to L) Dr Surinder Singh, DCGI, Chairman, Atul KR Nasa, Organising Secretary, Dr Arun Garg, Treasurer, releasing the registration brochure during the IPC LOC meeting in Delhi

The 60th Indian Pharmaceutical Congress (IPC), scheduled for December this year in Delhi, is slated to be a key platform for national regulatory authorities to unveil a regulatory roadmap. Speaking before the fifth Local Organising Committee (LOC) Meeting, Dr Surinder Singh, Drug Controller General India (DCGI) and also Chairman of this year’s LOC, disclosed key issues being put into action by his office which will be thrown open for discussion in the various workshops at the event. Ever since he has taken over as DCGI in February this year, Singh has been involved in scaling up recruitments. Of the 111 posts sanctioned, 56 new recruits are already in position.

Elaborating on his plans, the DCGI said, “My main thrust, as DCGI, at this year’s IPC is to put forward suggestions on how we can harmonise our regulatory mechanisms with international guidelines in areas ranging from medical devices, pharmacovigilance, clinical oversight mechanisms and quality audits of clinical trials. For instance, Form 44 needs to be harmonised with the Common Technical Document (CTD). I will also be proposing a regulatory blueprint for the Central Drugs Standard Control Organisation (CDSCO), which we are calling ‘CDSCO: Vision 2020’. Since the theme of the 60th IPC is “Pharma Vision 2020: Regulation for Better Healthcare” we thought this would be the most appropriate platform to initiate an industry-wide debate on these key issues.”

The ‘CDSCO: Vision 2020’ document will spell out the mission and goals of the CDSCO, along with the strategies to achieve these goals, with the milestones mentioned. Key topics for discussion will include the parameters for the accreditation of Clinical Research Organisations (CROs), the need for a pharmacovigilance centre in every medical college in India, the decision to put medical devices in a separate regulatory category, measures to curb the proliferation of counterfeit drugs and the framing of guidelines to regulate stem cells, radiopharmaceuticals, etc.

The DCGI pointed out that the harmonisation process is already underway as members of his office, including himself, have traveled to international regulatory agencies for exposure to global norms. Officials from World Health Organisation (WHO), US Food and Drug Administration (FDA) and Health Canada have conducted ‘train the trainer’ workshops of zonal drug inspectors, who will in turn, train their staff at the state level.

A key initiative is the e-Governance, where in a company can file, track and receive approval online. In the words of Singh, this will prove to be the panacea for the industry and the data collected will form a knowledge backbone. Starting this November, the DCGI’s office will follow strict timelines displayed in the lobby of FDA Bhavan.

Stressing the key role of media, the DCGI said that the press is the connector between the industry, regulators and the public at large. Since the topics up for discussion at the IPC would have a direct impact on the public, it would be the role of the media partners to the event, Express Pharma, to convey the right message to all stakeholders. Later, at the IPC LOC meeting, the DCGI released the Registration, Sponsorship and Souvenir brochures. Atul Kumar Nasa, organising secretary, LOC, informed the members present that the Delhi office of the LOC was now functional. The next meeting of the LOC is scheduled for October 18.