HISTORY
The Drugs Control Department was established in 1961, shortly after the formation of the State of Kerala as part of a nationwide effort to regulate the manufacture, distribution and sale of Drugs and Cosmetics under the Drugs and Cosmetics Act 1940. Before the formation of Kerala, drug regulation in the region was managed separately under the Travancore-Cochin administration. After the reorganization of states ,there was a need for a unified and structured enforcement mechanism in the newly formed state,w hich led to the creation of the dedicated department.
Quality of drugs is beyond the understanding of common man. It is the responsibility of the Drugs Control Department to ensure the availability of quality drugs to the public and the market is free from counterfeit; spurious and substandard drugs and no drugs are sold at a price higher than the retail price marked on the container .Additionally, the Drugs Control Department plays a crucial role in regulating and optimizing the use of potentially misused drugs and antibiotics by preventing their Over -The –Counter (OTC) sale
Expansion of Regulatory Functions
Over the years, the Department expanded its regulatory activities to include drug licensing, inspections, sampling and testing, prosecution of violations, price control, regulation of advertisements, poison licences and permits, and other drug-related regulatory functions.
Digitalisation of Office Records
In the earlier period, office records were maintained mainly in physical files. With the implementation of the e-Office system, the Department has transitioned to digital file management, enabling more efficient, transparent and streamlined handling of official records and files.
Expansion of Drug Testing Laboratories
In the earlier period, the Department had only one laboratory for analytical testing and related functions. The Department gradually strengthened its laboratory infrastructure to enhance the testing capacity and ensure effective quality control of medicines.
Today, Kerala has four Government Drug Testing Laboratories:
- Drugs Testing Laboratory, Thiruvananthapuram
- Regional Drugs Testing Laboratory, Ernakulam
- Drugs Testing Laboratory, Thrissur
- Drugs Testing Laboratory, Pathanamthitta (Konni)
These laboratories undertake testing of Allopathic, Ayurvedic and Homoeopathic medicines and cosmetics. The laboratories analyse approximately 11,500 samples annually.
NABL Accreditation
The Drugs Testing Laboratory, Thiruvananthapuram and Regional Drugs Testing Laboratory, Ernakulam have obtained NABL accreditation, strengthening the Department’s analytical capabilities and quality assurance system.The laboratories are equipped with advanced analytical instruments such as HPLC, GC, GC-MS, FT-IR, ICP-OES, AAS and UV-Visible Spectrophotometers.
Digital Transformation
The Department has progressively adopted digital systems for licensing and regulatory services. 2014 – Online system introduced for wholesale and retail drug sale licensing. 2017 – Online licensing system introduced for medical device manufacturing. October 2022 – Online National Drugs Licensing System (ONDLS) implemented for drug sale and manufacturing licences in Kerala.
Present Day – Citizen-Centric Drug Regulation
Today, the Drugs Control Department has evolved into a comprehensive regulatory agency working to safeguard public health and ensure the availability of safe, effective and quality medicines. Its activities include:
Drug licensing and regulation
Inspection and enforcement
Drug sampling and laboratory testing
Detection of substandard and spurious drugs
Blood Centre and Blood Storage Centre licensing
Poison licences and permits
Regulation of drug advertisements
Drug price control
Investigation of public complaints
Regulation of narcotic and other controlled medicines
Public awareness and consumer protection initiatives
1961 → 2026
65 Years of Protecting Public Health
1 Department → 4 Government Drug Testing Laboratories → 11,500+ Samples Analysed Annually → Digital Licensing → Citizen-Centric Drug Regulation
The Department Today – A Strong Regulatory and Analytical Network
Over the years, the Drugs Control Department has evolved into a comprehensive regulatory system with a strong Enforcement Wing and Analytical Wing, working together to safeguard public health and ensure the availability of quality medicines.
As of the latest available data, the Department regulates 210 Blood Centres, 98 Blood Storage Centres, 31 Allopathic manufacturing units, 15 Homoeopathic manufacturing units, 280 Cosmetic manufacturing units and 117 Medical Device manufacturing units. It also oversees 741 Recognized Medical Institutions, 432 Poison Permits, 3 Laboratory Approvals and 47,768 Sale Licences.
During 2025 (01/01/2025–31/12/2025), the Enforcement Wing conducted 7,216 inspections, issued 830 show-cause notices, recorded 334 suspensions and initiated 200 prosecutions, reflecting the Department’s continued commitment to effective enforcement.
The Analytical Wing received 12,136 samples and tested 11,044 samples, of which 234 samples were declared Not of Standard Quality (NSQ). These activities demonstrate the Department’s continuous efforts to ensure the quality, safety, efficacy and proper regulation of medicines and related products in Kerala.
Strengthening the Enforcement Network
Over the years, the Drugs Control Department has continuously strengthened its field-level enforcement network to ensure effective regulation across the State. The Department currently has 57 Drug Inspectors, supporting inspections, sampling, surveillance and enforcement activities throughout Kerala.
Drug control Department at a glance
DRUGS CONTROLLERS-KERALA STATE
| Sl. No. | Name | From | To |
| 01 | Shri. N.CHANDRASEKHARAN NAIR | 28.12.1966 | 30.04.1977 |
| 02 | Shri. P.M. VARKEY (In Charge) | 01.05.1977 | 15.04.1979 |
| 03 | Shri. V.J.THOMAS | 16.04.1979 | 30.04.1988 |
| 04 | Shri. D.KUMARAN NAIR | 01.05.1988 | 31.11.1991 |
| 05 | Shri. C.G . SUKUMARAN NAYAR | 01.12.1991 | 31.07.1994 |
| 06 | Shri. V.S PARASURAMAN | 01.08.1994 | 30.04.1997 |
| 07 | Shri. S.S. VENKATA KRISHNAN | 01.05.1997 | 30.09.2002 |
| 08 | Shri. T.P GOPINATHAN | 01.10.2002 | 28.02.2005 |
| 09 | Smt. G.SUDHA | 01.03.2005 | 31.03.2005 |
| 10 | Shri. A.ABDUL SHUKOOR | 01.04.2005 | 30.04.2006 |
| 11 | Shri. S.M. THAHA | 01.05.2006 | 29.02.2008 |
| 12 | Shri. M.P GEORGE | 01.03.2008 | 31.03.2010 |
| 13 | Smt. M.GEETHA | 01.04.2010 | 27.10.2011 |
| 14 | Shri. C.S SATHEESH KUMAR | 28.10.2011 | 31.10.2012 |
| 15 | Shri. P.HARIPRASAD | 01.11.2012 | 31.01.2017 |
| 16 | Shri. RAVI .S. MENON | 01.02.2017 | 30.04.2020 |
| 17 | Shri. P.PRAKASH BABU (In Charge) | 01.05.2020 | 31.05.2020 |
| 18 | Shri. K.J. JOHN | 01.06.2020 | 31.10.2021 |
| 19 | Shri. P.M.JAYAN | 01.11.2021 | 31.05.2023 |
| 20 | Dr. SUJITH KUMAR .K | 01.06.2023 |