In a move that promises to bring greater clarity to India’s regulatory process for pharmaceutical products, India’s regulator has announced plans to formalize a process for pre-submission meetings (PSMs). In a notice dated 28 January 2015, the Central Drugs Standard Control Organization (CDSCO) laid out proposed steps for the process.
Purpose and Precedent
PSMs are designed to help companies ensure their drug application submissions conform to legal, regulatory and scientific requirements. These meetings can also help to familiarize regulators with incoming submissions. By engaging in PSMs, companies and regulators can iron out potential issues before finalized dossiers are submitted to a regulatory authority, which can save valuable time for both parties.
Other regulators such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada offer formal PSMs to assist companies with questions related to submissions early on in the regulatory process. By formalizing the PSM process, CDSCO will bring a portion of its regulatory system more in line with those of its peers.
CDSCO says its new process was developed in response to stakeholders in industry asking for a “window for technical deliberations [with] regulators.” The agency believes formalizing this process will improve the transparency, accountability, predictability and timeliness of PSMs.
In the proposal, CDSCO lays out an eight-step process beginning with an applicant requesting a PSM for a new product or clinical trial. Applicants will then send a detailed proposal for the product or trial, as well as a payment for the PSM. After reviewing the application, CDSCO will notify the applicant of the meeting date, where the applicant will present their proposal to CDSCO officials. Following the presentation, the officials and applicant will discuss the regulatory and scientific aspects of the proposal and determine the appropriate regulatory pathway the applicant should take.
CDSCO says the discussions will be recorded, with signed minutes being sent to the applicant to be included with their formal submission. CDSCO notes that PSMs will be confidential, and advice will be specific only to the proposal discussed. Additionally, CDSCO maintains that PSMs are not required before submitting applications to the agency.
Stakeholders are requested to submit their feedback or suggestions for the proposal by 9 February 2015.
CDSCO sees 2015 as a year for change. Drug Controller General, Dr. G.N. Singh says CDSCO will be working to streamline regulatory procedures in 2015. CDSCO has also released a list of planned policy initiatives for 2015, which includes plans to amend the country’s Drugs and Cosmetics Act.