At the behest of the Department of Pharmaceuticals (DoP) under the Ministry of Chemicals & Fertilizers, the IDMA-Tamil Nadu & Pondicherry chapter and Pondicherry drugs manufacturers association (PDMA), are jointly organizing a workshop-cum-seminar on “shifting pharmaceutical industry from Schedule M to WHO-GMP compliance’ for the manufacturers of the Union Territory of Pondicherry on March 23.
The programme will include five technical sessions and a panel discussion by experts from DoP, Industry and Pondicherry government.
It is learnt that the DoP plans to give a holistic support to the pharma industry of Pondicherry to improve the business environment of the pharmaceutical and cosmetics sector there. According to sources, after a short period, the department will conduct a review on compliance of legal and ethical aspects of the drugs laws by each unit.
As far as Pondicherry pharma industry is concerned, some FDC related issues were emerged in 2013 which had in fact affected the whole pharma industry in the Union Territory and it impacted the business also. During the period, Pondicherry was in the news because of the issues which had emerged from the allegation that certain manufacturers had violated provision 122E of the D&C Rules. The Union Territory was found to have approved the highest number of FDCs manufactured without the prior approval of the DCGI. On inquiry, the health secretary to the UT government had to issue show-cause notices to 20 manufacturers operating there for violation of the provision. Besides, a central investigating agency had also conducted inquiry on the issue.
However, when the issues were over, the TN-IDMA had held one scientific workshop on December 19 in 2014 to educate the industry fellows on how legal and ethical issues had to be considered and applied in the day-to-day work of pharma production.
In spite of the issues, the drugs manufactured in Pondicherry were found to be perfect in quality and safety aspects and there was big demand in national level for the products manufactured there. Taking view of the quality aspects, the Department of Pharmaceuticals has now decided to give training to the manufacturing units on WHO-GMP compliance, said a source from TN-IDMA. The association has given notices to all the 200 manufacturers to compulsorily participate in the training programme.
On Friday, March 23, the programme will begin with an introduction on the subject by J Jayaseelan, chairman of IDMA-TN- Pondicherry state board. The chairman of IDMA’s Regulatory Affairs Division, SM Mudda, will deliver the opening address, according to information from IDMA.
Dr. V Candavelou, health secretary of Pondicherry is the guest of honour in the function. Deputy director of CDSCO, Shanti Gunasekharan will speak on the objective of the seminar. Senior officers from the department of pharmaceuticals will speak in the technical sessions to be held in the forenoon and afternoon sessions.
In the evening there will be a panel discussion on the subject “upgrading to WHO-GMP - challenges and opportunities”. SM Mudda will take the role of moderator and Dr. R Venkitesh, Dr. NR Kandaswami, C Venkitesh and Dr. V Candavelou will participate.
N Pramodh, president of PDMA will extend welcome and T Satheesh, secretary of TN IDMA will propose vote of thanks.