CDSCO announces one year extension of WHO-GMP certifications
The sixth edition of International Exhibition of Pharma and Healthcare (iPHEX), organised by Pharmaceuticals Export Promotion Council of India (Pharmexcil) set up by Ministry of Commerce and Industry, Govt. of India has begun in New Delhi. The objective of three-day event is to showcase the capabilities of Indian pharma industry to the global markets. The event is attended by key decision makers of the pharma industry, regulators and representatives from the ministry.
Suresh Prabhakar Prabhu, Minister of Commerce & Industry, Government of India gave the chief guest address. In his speech he touched upon various issues and challenges faced by the Indian pharma industry. Prabhu also cautioned about the increasing health burden of non-communicable disease across the globe and spoke on how the pharma industry should leverage the opportunities. He also pointed out that drying pipeline of innovative drugs and growing investment in research and development to develop newer molecules will throw up new opportunities. He also opined that focusing on biotech and biosimilar products can be the future for our industry.
He also pointed out the potential business opportunities existing in the African as well as LATAM markets. In his speech, he also mentioned about the initiatives being carried out by the Department of Commerce, Ministry of Commerce & Industry, and Government of India for Indian pharma industry in promoting the industry at global level. He informed that on March 26, 2018, a delegation from Chinese Commerce Ministry had visited India. They discussed on market penetration in India and had agreed to do a round table with their regulators to understand market requirements. While signing off, he also touched upon genomic-based science and how industry can work in sustaining traditional medicines through advanced science platforms.
The guest of honor at iPHEX 2018, Rita A Teaotia, Secretary, Department of Commerce, Ministry of Commerce & Industry, Government of India also spoke about the growth opportunities in the developing markets and how important it is to understand their regulatory frameworks. She also indicated that the next decade is going to be an era of biotechnology and biosimilars as many drugs are going off patent and across the globe we do not have strong research pipelines. So this opens a door for us to explore and grow rapidly. Teaotia also informed about cumulative data for the fiscal year 2017-18, which shows a modest 2.91 per cent growth to $17.27 billion from $16.78 billion in 2016-17, with annualised shipments increasing at a sharper rate, between 7-14 percent since November 2017.
Shyamal Mishra, Joint Secretary, Department of Commerce, Ministry of Commerce & Industry, and Government of India spoke on how the iPHEX platform can be a win-win situation for Indian pharma companies and international visitors as well as exhibitors.
Dr S Eswara Reddy, Drugs Controller General (India) shared a good news for the Indian pharma industry, and announced that the WHO-GMP Certification has been extended to three years. Until now, it was for two years. The CDSCO office will issue an official announcement in a couple of days. He indicated that this will is increase the ease of doing business and it was a long pending request from the pharma industry.
In his speech he also informed that in the last two years’ time there have been a rise of 300 per cent manpower in the regulatory framework. He also informed that the governing body has inspected 184 units of over 30 pharma companies and wherever they have found violation of rule and lack of adherance to WHO–GMP guidelines, the governing body, along with state regulatory body, are cancelling or suspending the manufacturers’ license. He also informed that in a bid to encourage clinical research in India, the CDSCO has issued a notice informing that if the applicants doesn’t receive communication from the applied regulatory authority within 45 days from application, then the applicants can consider their request as approved.
Madan Mohan Reddy, Chairman, Pharmexcil said that the present government is taking steps to make India a happening place and through iPHEX, is bringing all stakeholders under one roof. He announced that next year’s iPHEX will be held in Ahmedabad.
Dinesh Dua, Vice Chairman Pharmexcil delivered the welcome note and briefed on the capabilities of the Indian pharma industry.
Ravi Uday Bhaskar, Director General, Pharmexcil gave the vote of thanks. He informed that formulations as bulk drugs accounting for over 90 per cent of the Indian pharma exports have shown a sharp turnaround.