‘Quality is the watchword of Drugs available in Odisha’

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Hrushikesh Mahapatra
Drugs Controller under Health & Family Welfare Department of Government of Odisha

The Drugs Control Administration has ensured 3Ts – Teamwork, Transparency and Technology in Drug and Pharma administration and ensuring quality drugs are available in Odisha. In this regard, the state Drug Control Administration has introduced web automation in the entire operation process of drug licensing, monitoring, utilisation and enforcement. Hrushikesh Mahapatra, Drugs Controller under Health & Family Welfare Department of Government of Odisha shares the current strategy of Directorate of Drugs Control Administration in the State, in an interview with Biswajit Sahoo of Elets News Network (ENN).

Give us an overview of Odisha Drug Control Administration?

Directorate of Drugs Control (DDC), Odisha, functions as the head of the Drugs Control Administration in the State to ensure that the drugs made available to the people for disease prevention and treatment match the required standards of quality, purity and strength and are packed in specific containers that gives all necessary information about the drug and manufacturer. In brief, Drugs Control Administration regulates the manufacture, sale and distribution of drugs in the state of Odisha by implementing relevant central Drug and Pharmaceutical legislations in the state though its team such as

• Drugs and Cosmetics Act,1940 and Rules 1945

• Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 & Rules, 1955

• Drugs (Prices Control) Order, 2013 r/w Essential Commodities Act, 1955.

• Odisha Narcotic Drugs and Psychotropic Substances Rules, 1989. (For limited purpose)

In Odisha, the Drugs Controller, Odisha is the Controlling Authority and Head of the Department. Drugs Controller is also the Licensing Authority of the State for licenses to manufacture for sale of Allopathic drugs, Homoeopathic drugs and Cosmetics.

How do you operate in the State to ensure quality drugs are recommended by physicians and administered by patients?

The DDC in the State comes under the administrative control of Health & Family Welfare Department. The DDC functions mainly with two wings, i.e; Administrative and Testing wings. The administrative wing is headed by the Drugs Controller along with 44 Drug Inspectors, four Assistant Drug Controllers, four Deputy Drugs Controllers and 40 range officers in the field to watch and monitor.

The Testing wing or the State Drug Testing and Research Laboratory (SDT&RL) of Odisha functions with one Principal Scientific Officer and 42 more scientific officers and laboratory assistants.

The DDC has the mandate to execute certain statutory functions, so that quality drugs are available for public through sampling of drugs and cosmetics for test to ascertain their quality, monitoring of quality of drugs and cosmetics, manufactured in the State and marketed in the State with other licensing activities.

The DDC has also the mandate of grant and renew Blood Bank licenses to government institutions as well as to Private hospitals.

What is the broader role of Drug Control Administration?

To ensure quality drugs are available in the State, the Drugs Control Administration (DCA) grant/renew the sale of drug license and also keep a close watch over the enforcement made by the district drug inspectors, within the State of Odisha. DCA also checks/arrest movement of spurious/ adulterated/sub standard drugs sale as well as manufacture. Odisha has exemplary track records of exposing dubious and fake drug manufacturers in recent times which has been a case study now in Drug enforcement administration.

The DCA in Odisha also grants or renews manufacturing drug licences both in Allopathic and Homeopathic and grants and renews cosmetics manufacturing licences.

What are the IT integration strategies adopted by Drug Controller Administration in Odisha? Does it help in ensuring quality of available drugs apart from monitoring and enforcement?

The State Drugs Testing and Resarch Laboratory (SDT&RL) was established with the objective to test and analyse statutory drug samples under the provision of Drugs and Cosmetics act 1940 and Rules there under and to assess the quality of drug samples received from different sources like DCA and consumers in Odisha. The SDT&RL assists the enforcement wing to ensure the availability of quality drugs across the State. To ensure quality control through Good Laboratory Practices (GLP), SDT&RL has initiated an automation tool called Drug Testing and Data Management System (DTDMS).

The DTDMS is a web-enabled system, which facilitates the entire process of drug testing at laboratory and manages the data flow generated from the testing process. With this, all activities of the laboratory have been made automated and web based, so as to enable the users to retrieve the exact status, as and when required. It also digitises the test reports and generates the same instantly.

What are the other monitoring processes initiated by DCA?

The Drugs Control Administration has ensured 3Ts, Teamwork, Transparency and Technology in ensuring quality drugs available in the State. In this regard, the DCA with the support of National Health Mission, Odisha, is bringing automation in the entire operation process of drug licensing, monitoring, utilisation and enforcement.

The DCA has made detail plans and arrangements to introduce Licence Management System (LMS), a web based application to track and trace the licences, grant and renewals at different licensing zones of Directorate of Drugs Control. The system enables citizen interested in drug retailing, distributing and manufacturing, to apply online for their drug licenses. The process of verification and recommendation by the drug inspector and the approval of Licensing Authority are planned to be carried out online. The existing drug retailer, distributor and manufacturer can also renew/change their licenses in the system.

Another software tool for automation is Pharmacist Information Management System (PIMS). It is a web based application to facilitate the registration and renewal of pharmacists at Odisha Pharmacy Council. The database of pharmacists which are registered and renewed is uplinked with License Management System to enable the Licensing Authority of drugs and Drug Inspectors of the State to view the up to date status of the pharmacist vis-à-vis issue of drug license.

The DCA has also planned to introduce online Enforcement System to monitor the drugs manufactured, distributed or supplied in the State are of approved quality, label and licensed manufacturers. This system enables to investigate and monitor complains, issues by the team involving Drug Inspectors from sample collection and investigation in the field. It further gets approval from the Drug Controller and necessary actions are initiated as per the law for noncompliance to defaulters.

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