The Central Drug Authority of India (CDAI), the proposed new drug regulatory system in the place of Central Drugs Standard Control Organisation (CDSCO), will come up with a spectrum of 10 divisions to handle the various segments of regulatory and monitoring system under pharmaceutical sector, according to Prithviraj Chavan, Minister of State in the Prime Minister's Office (PMO).
While speaking as the chief guest of the 45th Annual Celebrations of Indian Drug Manufacturing Association (IDMA), he informed that the proposed authority under Ministry of Health and Family Welfare would have separate divisions to handle the segments including new drugs, biotechnology, pharmacovigilance, imports of pharmaceutical products, Quality Analysis, Indian Systems of Medicines, traditional medicines, international co-operation and patent of pharmaceutical production. The new establishment will be a unified body where the Drug Controllers and Assistant Drug Controllers would be upgraded with more training, he added.
"The new authority will be formed for sure, but it is not wise to comment on the time of establishment at present. We will take budgetary provisions sooner or later for the introduction of CDAI," Chavan told Pharmabiz later. "We are poised to play in the period of globalisation, where the industry should provide world class products and services to the customers globally. The government is committed to come up with reforms to help the industry, including steps to encourage acquisition business," he added.
The demands of pharmaceutical industry on financial incentives and R&D expenditure considerations would be addressed in the upcoming budget of central government. The government will also look into the proposals of the committee report, which was prepared under the chairmanship of Dr Mashelkar, on handling the issues of spurious and substandard drugs, informed Chavan.
Amitabh Chandra, Commissioner of Food and Drug Administration (FDA), Maharashtra said that one of the major issue faced by the FDA is the non-uniformity of provisions in various states, which lead to licensing of irrational combinations by different state drug authorities. The proposed CDA (I) would help to solve the issue as a centralised administration.
Being the Chairman of the sub-committee appointed by the government to look into the issues related to labelling, he also invited the responses and views of the industry on the implementation of new provisions. Addressing the meeting as the Chief Guest, he reiterated that the products, which have the nature of drug, should have a drug license though some of the manufacturers are looking for better options on the proposed Food and Safety Act to sell their products as nutraceuticals.
The IDMA is confident that the Ministry of Chemicals and Fertilisers will stand with its recommendations to continue the special provision and to increase the weighted deduction in its forthcoming budget, Suresh G Kare, president, IDMA commented. He said that the government should ensure that the country would not enforce TRIPS PLUS law that will cause a lot of harm to the country by brining in monopolistic situation in the industry. Considering the growing trend of Contract Manufacturing and R&D activities in the industry, the IDMA has selected 'Contract Research and Manufacturing Services (CRAMS)- Destination India' as its theme of the year, he informed.
The opportunities of Indian Pharma players in the global market has been explored by Shailesh Gadre, managing director, ORG IMS Research Pvt. Ltd., in the meeting. The new president for IDMA, B N Singh said that the Association would focus on helping its members to build up brands in the forthcoming years.