New drug approval process on the anvil

New Delhi: The NITI Aayog has proposed sweeping changes to the approvals process in the pharmaceutical and medical research sector in order to encourage innovation. NITI Aayog, with the Prime Minister’s Office in loop, has asked several ministries involved in the overall process of product (drug or vaccine) development, to streamline, update and simplify the process.

“There is lack of predictable regulations and approval timelines for innovation in the medical sector,” NITI Aayog said in a letter to the health ministry.

It also directed the ministry to convene a meeting of all the ministries involved and move forward on restructuring the process of granting approvals and reviewing the regulatory process.

Mint has reviewed a copy of the letter.

Different government institutions are involved at various stages in reviewing a company’s drug or vaccine claim before granting approvals. The steps involve assessing pre-clinical data and ancillary environmental concerns; examining the safety and efficacy of a product; and evaluating other technical aspects. The institutions involved in the process are the science and technology ministry, environment and forests ministry, Indian Council of Medical Research, health ministry and the Central Drugs Standard Control Organization.

Since it involves public health, a thorough evaluation of all the phases—from an innovation proposal to marketing of the product—can take over a couple of years.

NITI Aayog, however, wants the permission and approvals process to be cut short to 30 days. “Failing to process application within 30 days, it will be presumed as approved, like in the US,” suggests NITI Aayog.

In the US, the Food & Drug Administration prescribes a 30-day waiting period between the submission of an investigational new drug application and the start of clinical trials for the agency to review the prospective study.

“The FDA can order a ‘clinical hold’ to delay an investigation, or interrupt a clinical trial if problems occur during the study,” says the FDA on its website.

Implementing that in India—a month’s deadline or an automatic approval—may prove to be difficult because most government institutions involved in the process have a skeletal staff that sometimes lack the requisite skills.

Closer home, the involvement of the Review Committee on Genetic Manipulation, under the department of biotechnology, which monitors ongoing r-DNA projects and activities involving genetically engineered organisms and hazardous micro-organisms, may be axed at the research & development stage, as per the NITI Aayog’s proposal.

The proposal also includes strengthening the Institutional Biosafety Committee.

Each IBSC comprises the head of the institution or nominee as chairman, scientists specializing in rDNA work or molecular biology, an outside expert and a representative of the medical profession as members, along with a nominee appointed by the union government’s biotechnology department (under the Union science and technology ministry).

NITI Aayog’s suggestion entails shifting the prerogative of ensuring relevant checks and balances to the organization applying for approvals, as opposed to relying on the government’s machinery to do its job.

An organization’s IBSC is expected to meet at least twice a year to review the status of rDNA projects in the institution.

Questions emailed to NITI Aayog did not elicit a response.

Another suggestion from the erstwhile Planning Commission also includes a single-window application system to get approvals from various agencies.

It also suggested pre-approval meetings with different government agencies to understand their requirements.

“A single-window clearance for drug or vaccine approvals is extremely unlikely unless there’s a broad consensus first on the how the approval system is to be re-engineered,” said an official from the Union ministry of health and family welfare, requesting anonymity.