Centre Tightens Vigil In Pharma Hub Baddi, Reorganises CDSCO Zone Amid Drug Quality Concerns

Last Updated:February 28, 2026, 02:58 IST

The move comes as the government steps up inspections and enforcement measures, including Risk-Based Inspections across manufacturing clusters, after a spate of quality failures

Amid rising concerns over drug quality and repeated regulatory red flags, the Centre has moved to tighten oversight in Baddi—one of India’s largest pharmaceutical manufacturing hubs—by restructuring the Central Drugs Standard Control Organisation (CDSCO), India’s apex health regulatory agency, in the region.

In an order dated February 27, 2026, seen by News18, CDSCO has decided to reorganise Baddi into three separate sub-zones in view of the “vast geographical spread, large number of regulated establishments, and operational constraints". Baddi houses a dense cluster of pharmaceutical and formulation units that supply medicines across India and for export and has in recent years faced scrutiny following multiple instances of substandard drug findings by domestic and overseas regulators.

The move comes as the government steps up inspections and enforcement measures, including Risk-Based Inspections (RBI) across manufacturing clusters, after a spate of quality failures.

Under the new structure, the Baddi Zone has been split into Baddi-I Sub-Zone, Baddi-II Sub-Zone, and Chandigarh Sub-Zone, each to be headed by an assistant drugs controller (ADC).

What will change now?

Baddi and the larger Baddi-Barotiwala-Nalagarh (BBN) industrial area are known as one of the country’s largest pharmaceutical manufacturing clusters, with industry estimates suggesting that around a thousand formulation and bulk drug units operate in the region. The belt hosts a mix of major pharmaceutical companies as well as smaller contract and third-party manufacturers, supplying medicines to domestic and export markets.

With the reorganisation, each ADC heading a sub-zone will function independently for regulatory and enforcement activities within their assigned jurisdiction. This includes planning and conducting inspections, investigations, and other regulatory actions in accordance with existing rules and guidelines.

The order states that the ADC(I)s “shall function independently in respect of all day-to-day regulatory and enforcement activities within their assigned jurisdictions", including “planning and conduct of inspections, investigations and other related regulatory actions".

Consequent to the restructuring, the Deputy Drugs Controller (India), Baddi Zone, will now perform coordination functions across the three sub-zones rather than directly handling all enforcement activities. The DDC will be responsible for driving the execution of recommended actions arising out of risk-based inspections or corrective action and preventive action (CAPA) and other audit observations, along with operationalising the new CDSCO office building at Baddi. The officer will be responsible for coordinating and facilitating National Regulatory Authority (NRA) assessment for drugs, particularly in respect of vaccines and regulatory systems.

The order further assigns the DDC Baddi the task of driving and monitoring the upgrade of the Central Drugs Laboratory (CDL), Kasauli, and carrying out any other work assigned by the CDSCO headquarters from time to time.

The reorganisation signals a sharper administrative focus on Baddi at a time when regulatory scrutiny of manufacturing standards has intensified.

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