Paying heed to a long-standing plea, India has, finally, decided to start a system for companies to formally meet the regulatory agency before filing to obtain clearances for clinical trials, new drugs and medical devices.

The introduction of Pre-Submission Meeting (PSM) provides an opportunity for the applicants to work out the various technical and regulatory aspects of the products they are seeking approval for, directly with the concerned agency staff and subject experts before they go on and file the submission.

Central Drugs Standard Control Organization (CDSCO), the office of India’s top drug regulator, expects PSM will open a new window for companies to get to know the appropriate requirements and understand the regulatory pathways to be followed for specific applications.

Observers say holding such discussions would be of immense help especially for companies located abroad, which are often in the dark about the nitty-gritty of the Indian regulatory process. Many times, such applicants end up running pillar to post leading to unnecessary delays. A clear understanding of the process, beforehand, can facilitate ease of approval.

Besides cutting short the approval time-lines, PSMs would bring in transparency, accountability and predictability in processing and disposal of cases, according to a CDSCO notification announcing the decision.

Approvals Get Predictable
Explaining the various steps involved in the process, CDSCO proposes the applicants seeking PSM to make a formal request to the agency submitting the details of their proposal. The request should contain “regulatory pathways proposed to be followed with justification keeping in view the regulatory requirements as specified in the Drug and Cosmetics Act and Rules”—India’s rule book governing pharmaceuticals, medical devices, and clinical trials—along with the specified fees. The agency would then review the application and subsequently inform the date and time of the meeting. 

During the meeting, the companies can present their case in detail before the regulatory officials, including subject experts. The committee will discuss the proposal at length with the applicant “keeping in mind the regulatory, as well as scientific aspects relevant to the proposal.”

It is worthwhile, in this connection, to note that the government approved more than two dozen subject expert committees last month advising the regulator on various therapeutic categories as the latest in a slew of reforms launched in the clinical research sector in recent months. 

After deliberations the agency will decide on the regulatory pathways to be followed for the specific product based on the information provided by the applicant.

The CDSCO notification makes it clear that regulatory pathways agreed on by the agency and the applicant would be limited to the specific application deliberated, and would not be binding “for any other applications of the same applicant or any other applicant.”

Not Mandatory
The agency, as a measure to address any possible concern by the filing companies, assures that all the details of discussion will be held confidential. It will record the proceedings and prepare the minutes of the meeting, and get it attested by the attendees including CDSCO officials, subject experts and the applicants.

CDSCO, in turn, will issue one copy of the minutes of proceedings to the applicant. Companies can submit this copy along with their formal application for obtaining regulatory approval. It will ensure that further action on their filing has been taken along the lines of the regulatory pathways agreed upon by both parties.

However, PSM is not made mandatory for all the companies seeking approval for conducting clinical studies or for marketing therapeutics and devices. In other words, the authorities do not insist applicants on PSM as a precondition for seeking regulatory approvals. It is optional. The CDSCO notice also clarifies that the company can prefer not to go for it and is free to submit any application, even without PSM.

The CDSCO move to introduce PSMs is seen as part of its ongoing effort to make the country’s regulatory apparatus more responsive and accountable. India is also working on its patent IP laws. Efforts are underway to broaden the scope of its Drugs & Cosmetics Act 1940, as well.

Though CROs, in general, are a bit wary of some of the newly launched provisions, they look at PSMs as something that can offer more predictability in many cases, instead of waiting a long time with the uncertainty of not knowing whether or not the proposal has been rejected.