The Central Drugs Standard Control Organisation (CDSCO) is moving towards a more risk-based and proportionate regulatory framework for the pharmaceutical sector, with an emphasis on reducing unnecessary interventions, simplifying processes and speeding up approvals

Dr. Ranga Chandrashekhar, Joint Drug Controller, CDSCO, Ministry of Health & Family Welfare, Government of India, said the regulator is reviewing the drug approval pathway to identify areas where regulatory intervention can be reduced while maintaining necessary safeguards.

Speaking at a panel discussion on rationalising criminal provisions governing business and regulatory compliance at iPHEX 2026, organised by Pharmexcil, Chandrashekhar said some regulatory requirements had already shifted from prior approval to prior intimation.

He cited manufacturing for test and analysis before approval as one such area, saying the approach could help reduce processing time. He also pointed to standardised clinical study designs and guidance for bioavailability and bioequivalence studies, enabling prior intimation for generation of data intended for export purposes. 

The CDSCO is also expanding the use of digital systems, dashboards and supervisory mechanisms to improve oversight and reduce processing times. Chandrashekhar said the Jan Vishwas framework had prompted a review of certain procedural and record-keeping offences to ensure that regulatory responses were proportionate to the nature and seriousness of the violation.

In appropriate cases, he said, offences could be compounded through monetary penalties while retaining deterrence for more serious violations.

The principle of proportionality was also highlighted in the regulation of controlled substances. 

Brijendra Chowdhary, IRS (Customs & Indirect Taxes), Deputy Narcotics Commissioner, Central Bureau of Narcotics, said regulation should enable legitimate pharmaceutical activity while preventing diversion and trafficking.

“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,” Chowdhary said.

He added that the Central Bureau of Narcotics was working towards greater self-regulation and voluntary compliance within the industry through increased engagement and awareness. He also noted that amendments to the Narcotic Drugs and Psychotropic Substances (NDPS) Act are under consideration, with proportionality forming part of the deliberations.

Dr. Sonali Rawal, Senior Health Specialist, NITI Aayog, said regulatory reform should not be viewed as an attempt to eliminate necessary regulation, but rather as an effort to simplify processes where delays can be avoided.

“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,” Rawal said.

From the industry perspective, Dr. Amit Talwar, Associate Secretary General, Indian Pharmaceutical Alliance, said regulatory reform should not be equated with weaker standards.

“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,” Talwar said.

Meera Vanjari, Chief General Counsel, Cipla Ltd., said greater proportionality would also require regulations to be clearer, more objective and consistently interpreted.

“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,” Vanjari said. 

K. Raja Bhanu, Director General, Pharmexcil, said regulatory clarity and predictability were increasingly important for Indian pharmaceutical companies, particularly exporters and MSMEs competing in global markets.

“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,” Bhanu said.