CDSCO moves to risk-based regulation to simplify drug approval process

CDSCO is implementing a risk-based regulatory framework to simplify processes and reduce intervention without compromising drug quality. This approach, part of the Jan Vishwas framework, focuses on proportionality in compliance and penalties.

The Central Drugs Standard Control Organisation (CDSCO) is moving towards a smarter, risk-based regulatory approach that reduces and prioritises intervention, simplifies processes and applies greater proportionality to compliance, while continuing to safeguard the quality, safety and efficacy of medicines, Dr Ranga Chandrashekhar, Joint Drug Controller, CDSCO, Ministry of Health & Family Welfare, said during a panel discussion at iPHEX 2026 organised by Pharmexcil, according to a release.

Simplifying Processes, Retaining Deterrence

Speaking at a session focused on rationalising criminal provisions governing business and regulatory compliance, Chandrashekhar said CDSCO has examined the drug approval pathway to identify areas where regulatory intervention can be reduced without compromising quality. He pointed to measures where certain requirements have moved from prior approval to prior intimation, including manufacturing for testing and analysis before approval, helping reduce processing time. He also said that for BA/BE studies, clinical study designs are standardised and adequate guidance is provided, enabling prior intimation for generation of data for export purposes.

He also highlighted CDSCO’s increasing use of digital systems, dashboards and supervisory mechanisms to reduce processing time and improve oversight. Referring to the Jan Vishwas framework, Dr Chandrashekhar said certain procedural and record-keeping offences have been reviewed to ensure that the regulatory response is proportionate to the nature of the lapse, with compounding the offences with monetary penalties available in appropriate cases while retaining deterrence.

Proportionality in Controlled Substances

Extending the principle of proportionality to controlled substances, Brijendra Chowdhary, IRS (Customs & Indirect Taxes), Deputy Narcotics Commissioner, Central Bureau of Narcotics, said regulation should facilitate legitimate pharmaceutical activity while maintaining strong safeguards against diversion.

Brijendra Chowdhary said, “The challenge is to enable legitimate economic expansion of the pharmaceutical industry while preventing illicit diversion. Regulation must serve as a protective guardrail, not as an operational hurdle. There should be proportionality, a clear distinction between a legitimate error and malfeasance, risk-based enforcement, and zero tolerance against drug trafficking and diversion.” He added that the Central Bureau of Narcotics is working towards an ecosystem of self-regulation and voluntary compliance, supported by greater engagement and awareness among industry. He also noted that the NDPS Act is undergoing a process of amendment, with the principle of proportionality forming part of the deliberations.

Policy and Industry Align on Proportionality

The broader policy thinking was reinforced by Dr Sonali Rawal, Senior Health Specialist, NITI Aayog, who said the government’s approach is not to do away with necessary regulation, but to simplify processes where delays can be avoided. Rawal said, “The underlying basis of this process is trust, what we call Jan Vishwas. We work with the premise of trust in industry partners and regulators, and where processes can be undertaken in parallel or unnecessary requirements can be simplified to hasten approvals, we should look at doing so.”

From the industry side, Dr Amit Talwar, Associate Secretary General, Indian Pharmaceutical Alliance, said regulatory reform should not be interpreted as a demand for weaker standards. Talwar said, “When we say deregulation, we are not asking for abolition of regulation. Medicines are different from other industries because public health, safety and efficacy are involved. What we are saying is that there has to be proportionality. An issue involving misconduct or intent should not be treated at par with a violation in a documentary process.”

Call for Clarity and Competitiveness

Building on this, Meera Vanjari, Chief General Counsel, Cipla Ltd., stressed that greater proportionality also requires clearer and more consistently interpreted regulations, the release said. Meera Vanjari said, “We do not want to dilute regulations. What we would definitely like to see is that regulations are more specific, objective, easy to interpret and not open to subjectivity. For minor offences such as documentation not being in order or missing certain deadlines, there should be other ways of dealing with them, including compounding, while ensuring that penalties remain a deterrent.”

K Raja Bhanu, Director General, Pharmexcil, said, “For Indian pharmaceutical companies, particularly exporters and MSMEs, regulatory clarity and predictability are critical to competitiveness. A smarter, risk-based approach can reduce avoidable compliance burden while maintaining the standards expected in global markets. This balance between strong regulation and ease & speed of doing business will be important as India strengthens its position as a trusted pharmaceutical partner worldwide.”

The discussion reflected a broad convergence that ease of doing business in pharmaceuticals does not mean weaker regulation, but a more risk-based and proportionate framework that simplifies compliance for legitimate businesses while retaining strong safeguards around quality, safety and serious violations, the release said.

The discussion formed part of iPHEX 2026, the 12th edition of India’s flagship pharmaceutical exhibition, organised by Pharmexcil with the support of the Department of Commerce, Ministry of Commerce and Industry, Government of India, under the Bharat Health Global Expo 2026 at Bharat Mandapam, New Delhi. With more than 800 stalls, 600 hosted international buyers, around 30,000 business visitors, and 10,000 business meetings. Pharmexcil is targeting approximately USD 1.4 billion in export business opportunities through iPHEX 2026. (ANI)

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