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TN DCA gearing up for inspection of pharma units to ensure compliance with revised Schedule M
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Peethaambaran Kunnathoor, Chennai
January 08 , 2025
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It is learnt from the speech made by the director of the Tamil Nadu Drug Control Administration (TN DCA), M Sridhar, at the Regional Training Programme (RTP) of the Central and state regulatory officers in Chennai that the department is gradually gearing up for inspection at the manufacturing facilities of the pharma companies to ensure compliance with the conditions put by the Union government with regard to revised Schedule M.
While delivering the keynote address at the three-day training program at the Anna Administrative Staff College in Chennai, M Sridhar exhorted the participating enforcement officials to be ready for strict enforcement of the Drugs and Cosmetics Act in the wake of recent amendments including Schedule M. He wanted the regulatory officers to improve their skill and knowledge to conduct strict inspections in manufacturing facilities to ensure compliance of quality assurance and revised Schedule M norms. He said the government of India as well as the state government wants to produce and market only quality products.
The capacity building training program is organised by the Central Drugs Standard Control Organisation (CDSCO) for the regulatory officers of Tamil Nadu, Kerala, Pondicherry and Karnataka’. It will culminate at 4 pm on January 8.
Welcoming the participants, the joint drugs controller at the CDSCO in New Delhi, Dr. S Eswara Reddy, said the officers should upgrade their skill and knowledge about regulatory requirements specified in the drug act, similarly they must be aware of the periodical amendments. He said, since CDSCO does not want to compromise on quality aspects, the regulators should become fully prepared for strict inspections in the wake of the revised good manufacturing practices.
The deputy drugs controller at the CDSCO office in Chennai, Dr KM Srinivasan, said so far no information his office has received from Delhi with regard to inspections based on the new GMP. He said the training programme is well organised by his office in order to upgrade the standard and skill of the drug inspectors and ADCs. Training is given on various areas of the regulatory requirements.
Drug inspectors, senior drug inspectors, regional drug inspectors and assistant drug controllers from Tamil Nadu, Pondicherry, Kerala and Karnataka are participating in the programme.
On the first day, January 6, the training programme started with the class of Dr S Eswara Reddy on the subject, ‘Revised Schedule M - Data for Product Approval’. Followed by it, there was a talk by Sourav Ghosh, associate director, quality operation head at Cipla. The subject of the speech was ‘Validation of Pharmaceutical Water System’.
Afternoon programme started with the speech of Dr K M Srinivasan, deputy drugs controller, CDSCO, in Chennai, on the subject, ‘General Non Compliances Observed during Inspections’. The last session was handled by Yogesh Kumar Joshi, senior general manager at Sun Pharma. He talked on ‘Concept and Definition of OOS, Change Control, Deviation and Self Inspections’.
V M Bharathy, deputy drug controller (I) at CDSCO headquarters in New Delhi handled the session in the afternoon, he talked on’-Regulation of Blood Centres -General Non-Compliances observed during inspections’.
Former assistant drug controller at the FDA Bhavan in Haryana, Rajendra Harna, took a class in the second session which covered various areas of inspections. His subject was, ‘Investigation Techniques and Launching of Prosecutions, Bailable and Non-bailable offences, Method of Investigation of NSQ and Spurious Drugs, Presenting Evidence in the Court Facing Cross Examination.
Nilesh Kumar Saluja, head of regulatory affairs at Mylan Laboratories Limited delivered a talk on ‘Qualification of HVAC Systems, Area Qualification - Sterile and Non-Sterile Area’. Followed by it, a talk was made by Adv. Rishi Kant, Legal Advisor of the CDSCO in New Delhi. The subject he selected was, ‘Drugs and Cosmetics Act and Rules including Special Court, Cognizable and Non-Cognizable Offences, Compounding of Certain offences, Summary Trials and Union of India vs Ashok Kumar Sharma case.
The last session was on ‘Narcotic Drugs and Psychotropic Substances Act and Rules’ and the speaker was Dr. Naresh Sharma, Deputy Drugs Controller at CDSCO (HQ) in New Delhi.
Today, January 8, the program will begin with a session to cover ‘Medical Device Regulations’. Aseem Sahu, Deputy Drugs Controller at CDSCO (HQ) in New Delhi will lead the session.
In the following session, the Assistant Drugs Controller at Drugs Control Department in Karnataka, S Venkatesh will talk on ‘CDSCO Guidelines for taking action on samples of drugs declared spurious or NSQ’. There will be a discussion for one hour in the afternoon on price control, in which officers from the NPPA will participate.
The final session is for stress management in the profession. The speaker is Dr Sivakumar Bellan, Career Coach and Professional Trainer in Pondicherry. The programme will end at 5 pm.
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