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 MN Sridhar, director of the Tamil Nadu Drugs Control Department, talks about the steps taken by him as the head of the department in maintaining the quality of medicines manufactured and marketed in the state. Also, he speaks about how the pharmaceutical industry in the state is gearing up for the implementation of the Revised Schedule M, and how far the inspectors in the department have become competent to inspect the manufacturing facilities, as well as the medical devices manufacturing companies.
In an interview with Peethaambaran Kunnathoor, our special correspondent in Chennai, Sridhar says that the drug inspectors have been already trained by imparting knowledge on recent advancements in regulations, like inspections based on the Revised Schedule M, as well as on current regulations on medical devices.
Sir, you were promoted and appointed as the director of the Tamil Nadu drugs control department (TN DCA) in December 2024. What changes have you brought about in the department so far to make the regulatory body a stronger one, and what are your plans for the future?
Frequent training was conducted for the drug inspectors and senior drug inspectors to impart knowledge on recent advancements in regulations, like inspections based on the Revised Schedule M, as well as on current regulations on medical devices. The number of samples to be drawn for testing and analysis has been increased. Steps were taken to establish an exclusive medical device testing lab at Coimbatore. In addition to all these, I took the initiative to construct several zonal office buildings and one new building for the head office at the DMS campus in Chennai.
As the head of the department, what measures were taken by you to maintain the quality of the drugs available in the market?
To monitor the quality of drugs available in the market and at government institutions, the number of samples to be drawn for analysis has been increased. Further, specific SOP was devised for drawing of samples, including LVPs, antibiotics, cardiovascular products, cosmetics and veterinary medicines.
There are instances of seizure of falsified, substandard and even spurious medications from the premises of drug traders in myriad places in the state. Was there any offender punished in cases taken by the department in the last one year? If so, please share the details.
A total of 74 prosecutions were launched for the manufacture and sale of not of standard quality (NSQ)/spurious drugs in the last one year. Besides, fifty product approvals were suspended, and three product approvals were cancelled for the same offence.
Govrnment of India has now mandated that all pharma companies must comply with Revised Schedule M of the D&C Act to ensure high quality in production aligning with global standards. What steps have been taken by your department in support of it?
Inspections were conducted before the effective date of Revised Schedule M and their preparedness for implementing the New Schedule M. Based on the observations, the manufacturers have been requested to upgrade their facilities.
Based on the upgraded Schedule M, have you started inspections in the manufacturing units? How many of the big players in Tamil Nadu have already complied? What is the progress in the small-scale sector?
Inspections were conducted before the effective date of Revised Schedule M. We will conduct inspections after the lapse of time period to make applications for extension to the Central Licence Approving Authority. We support MSMEs by providing them guidance for the upgradation of their units.
It is said that the regulatory officers in the department need to be trained on risk-based audits and quality control. How far are your inspectors and ADCs competent in conducting inspections based on the revised GMP?
Workshops and training programmes are being conducted to the drugs inspectors and senior drugs inspectors. Revised checklist was also prepared and made effective in the department.
Similarly, competency is required for regulators to conduct inspections on medical devices and in their manufacturing sites. How skilful are the officers of your department in carrying out inspections in these companies by understanding ISO 13485?
Checklist as per ISO 13485/QMS of Medical Devices Rules 2017 is available with this department from its effective date. Regular inspections are being conducted at the Class A and Class B medical devices manufacturing units. Even under the centrally sponsored scheme, funds were allocated for establishing an exclusive medical devices laboratory at Coimbatore.
What are the educational programs and training your department is conducting to increase the skill and efficiency of drug inspectors?
Frequent training on GMP, QMS and also on legal provisions is conducted by the government.
How is the CDSCO coordinating with TN DCA to ensure uniform enforcement of drug rules to maintain the quality and efficacy of drugs, cosmetics and medical devices manufactured and marketed in the state?
CDSCO, South Zone is in good terms with the drug control department. However, there are few differences in technical matters on the applicability of law within the prerogative of the SLA and Controlling Authority.
Recently, in West Bengal and other parts of the country, huge quantities of counterfeit medicines were seized by the regulators. Some of the drugs were manufactured in south India. Do you find any kind of falsified medicines in the market or industry in the state? How do you rate the manufacturers in Tamil Nadu?
Last year one drug was reported as spurious in the state, but it was not manufactured here, it came from another state. In the case of Tamil Nadu, no drug manufactured by the domestic manufacturers was reported as spurious or counterfeit in the last three years.
There is an allegation that counterfeit and substandard drugs are entering the market through marketing companies’ channels. They manufacture the drugs in north India and market the products to hospitals, doctors’ clinics and to discount/chain pharmacies who are selling medicines at discounted rates. Do you have any provision to control the discount pharmacies or ask them to remove the discount boards from the shops?
We are concentrating on the sale of drugs through marketing companies. Samples are drawn regularly from marketing companies. If reported adversely, legal actions are taken against both manufacturer and the marketing company as per law. Pricing of medicines only falls under the DPCO, 2013 under EC Act 1955. There are provisions to take legal action if medicines are sold above MRP. But no provision is available in both the drugs rules 1945 and DPCO 2013 to take action if drugs are sold at discounted prices.
Finally, I would like to ask you some questions related to actions taken by the department in the last two years. How many prosecutions were launched in Tamil Nadu during the last two years for violation of DPCO 2013? Also, how many prosecutions were launched during this period against firms for manufacturing and selling NSQ drugs?
In the last ten months, the department issued 221 prosecution orders for violations of various provisions in the D&C Act 1940, and the Rules 1945. As administrative action, the department suspended 327 retail licences and 54 wholesale licences, while 45 licences including retail and wholesale were cancelled. Steps were taken to prosecute 65 drug manufacturers for manufacturing NSQ drugs.
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