Pharma EM issues not as straightforward: Experts

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Conference attended by regulatory affairs experts and pharma companies

As more pharmaceutical companies in India target emerging markets to fulfill their growth ambitions, they often stumble when it comes to navigating the regulatory landscape within these markets. Many of these issues and challenges were discussed at the recently concluded ‘International Conference on Regulatory In Emerging Markets’ organised by Alliance India in Mumbai. The meet was attended by global regulatory affairs consultants and regulatory affairs personnel from various pharma companies.

The conference was inaugurated by Chairperson Hasumati Rahalkar, Founder and Managing Director, Metina PharmConsulting who stressed that accessing emerging markets (EMs) is not as straightforward and easy as it may first appear. Competition and business models will vary with product portfolios and regulatory frameworks and patent positions will give additional challenges across the regions.

While day one focused on China, Brazil and Mexico, the following day looked at Russia, GCC and MENA, and South Africa. Besides the region specific sessions, experts also dissected issues related to country-specific requirements and trends.

Nitin Gaikwad, General Manager, Regulatory, Lupin, gave a detailed information about the China market including China FDA regulations and technical requirements. Rahalkar spoke about latest international concept about super generics in emerging markets. Mature generic companies are looking for differentiation in products portfolio, better pricing and patient compliance, she said.

Rahul Gupta, General Manager, Regulatory Affairs, Piramal Enterprises spoke on ‘Global regulatory requirement and process for NDDS formulation for smooth and speedy approval’ while Santosh Savarkar, Associate Vice President, Regulatory Affairs, Alembic, emphasised that GMP inspection remains GMP irrespective of the US, EU or any emerging market.

On the following day, Santosh Kashyap, General Manager Regulatory Affairs, Dr Reddy’s Laboratories briefed the audience about the steps to be followed for the South Africa market. He gave information about the fee pattern, registration process and time line for the approval process in South Africa. Kashyap also intimated that many government policies are likely to come into effect by 2016. He said that 2016 seems a magical year for MCC as many things are in the pipeline and the government has planned to implement it from April 2016. Say for example, the Government of South Africa will make braille mandatory on medicine packaging. It is likely that the medical device industry will get formal guidelines by 2017 which are in currently at draft stage.

He also highlighted section 21 which is a special route to get an approval from MCC in a special approval category.

Beena K Shah, General Manager, Regulatory (International) Geltec discussed pharma business opportunities in GCC and the MENA market. She informed that most issues in the GCC and MENA markets are controlled by the government, resulting in ‘protectionism.’ She opined that regulation is always evolving and needs constant updation.

She added that GCC regulatory approval comes much faster than developed countries. She also talked about the importance of halal and pork residue certifications for the approval process, as there are cultural and religious aspects attached to it. The MENA market is currently only two per cent of the global pharma market but is slated to increase, considering the requirements for medicines in different therapeutic areas.

The conference also covered the possibilities and needs of developing pharma markets. There is a need for skill-based medicinal products and Indian pharma companies should grab these opportunities. During the two-day long conference, speakers discussed how pharma companies in India can relate to the disease profile prevalent in GCC and MENA countries and are therefore in a position to read the market needs better. For example, Indian pharma companies can relate to disease profiles like malaria, as they are common to both regions, while simultaneously servicing other therapeutic sectors like diabetes, cardiovascular diseased and AIDS.

The two-day conference, held in Mumbai and organised by Alliance India, was attended by regulatory experts from various pharma companies.

(With inputs from Sachin Jagdale and Usha Sharma)

EP News BureauMumbai