The Pharma Corner

This page will carry a selection of issues facing India’s pharma industry and the face-off between public health and private industry:

2) India ramps up biotech R & D with academia-industry initiative: (BioWorld, Aug 22, 2017)

India launched its first formal industry-academia mission to ramp up its biopharma development by promoting entrepreneurship and indigenous manufacturing to transform the country into a global hub for cutting-edge biotechnology R&D.

The mission was launched in New Delhi by India’s Union Minister for Science and Technology Harsh Vardhan at the end of June.

Vardhan said during the launch of the industry-academia mission that it “is anticipated to be a game changer for the Indian biopharmaceutical industry” and “it aspires to create an enabling ecosystem to promote entrepreneurship and indigenous manufacturing in the sector.”

The flagship program of the mission is ‘Innovate in India’, or ‘i3’, which involves a total investment of $250 million including a $125 million loan from the World Bank. And the program will be implemented by the public-funded Biotechnology Industry Research Assistance Council (BIRAC) under the Department of Biotechnology (DBT).

DBT Secretary and BIRAC Chairman KrishnaswamyVijayRaghavan said that the endeavor would help nurture next-generation technical skills, promote entrepreneurship and support institutions in adoption of global innovations, technologies and licensing models.

The program will be driven by global experts, industry leaders and the World Bank to ensure world-class biomedical products are born out of the initiative.

Currently, India has only a 2.8 percent share in the global biopharmaceutical market, and the program aims to almost double it to 5 percent and generate additional business opportunities that are worth $16 billion. The ‘Innovate in India’ program will focus on the development of new vaccines, bio-therapeutics, diagnostics and medical devices to better address the rising burden of diseases in the country, according to the DBT.

It also aims to bring isolated centers of excellence together, enhance regional capabilities, strengthen the capacity of the current bio-clusters network, help deliver 6-10 new products within the next five years, create several dedicated facilities for next-generation skills and generate hundreds of jobs.

Kannan Vijayaraghavan, CEO of Sathguru Management Consultants Pvt. Ltd., a Hyderabad-based industry analyst who released a white paper on the Indian biosimilars industry in October 2016 with the Associated Chambers of Commerce and Industry in India (ASSOCHAM), told BioWorld that the new mission is expected to have major impact in three areas: development of high-cost, unaffordable vaccines such as those for human papillomavirus (HPV) and pneumocystis pneumonia (PCP); low-cost biosimilars; and early diagnostics for diseases by building capacity in companies in device manufacturing and validation.

It could also propel forward the tardy industry-academia collaboration in India’s biopharmaceutical sector.

“India lacks collaboration between public-funded and private-funded players at various stages of development, such as product validation and entry into market,” said Vijayaraghavan.

In the U.S. for example, early-stage development involves research collaboration and financial or investment collaboration among academia and industry, he observed. “But when firms work in isolation and do not pool together, as in the case of India, then they take a longer time to develop and market a product.”

Small Indian firms require support in three critical areas: core infrastructure as most small Indian companies cannot afford to build all the core infrastructure required; intellectual property rights regulation; and skilled human resources, said Vijayaraghavan.

The mission hopes to enhance infrastructure by offering access to a common technology and validation platform to help conduct pilot studies, safety studies and product validation studies.

Development of biosimilars – one of the mission’s main goals – has been the focus of the Indian biotech industry in recent years, and industry analysts have been pointing out the need for more collaboration in the biosimilars segment.

The ASSOCHAM-Sathguru white paper released in 2016 said that India was very well placed to tap into the biosimilars opportunities expected in the next 15 years, with its domestic market poised to grow to $40 billion by 2030, against a backdrop of an expected $240 billion growth in the global market by 2030.

The Indian biosimilars segment has built a strong foundation that requires appropriate commercial strategies and policy environment to succeed.

Several Indian firms such as Dr. Reddy’s Laboratories Ltd., Hyderabad; Biocon Ltd., Bangalore; ZydusCadila Healthcare, Ahmedabad; Intas Pharmaceuticals Ltd., Ahmedabad; AurobindoPharma Ltd., Hyderabad; and others have already made concerted investments and are at an advantageous position to participate in this lucrative market.

But there is a need for collaboration to accelerate time to market, the paper noted. These include asset-level collaborations for technology access which could accelerate time to market and global competitiveness; and risk-sharing co-investment collaborations, both with multinationals as well as with Indian companies, to break market barriers in developed countries.

India’s new biopharma mission was launched amidst a generally positive outlook for the sector in the country. The latest December 2016 Moody’s report, for example, said that Indian pharmaceutical companies would continue to seek growth through the acquisition of overseas assets in two years, aimed at deepening their geographic and product diversity, and increasing their presence in developed and emerging markets.

“The drive for overseas expansion comes amid global pharmaceutical industry consolidation, as drug companies look to boost their product and pipeline diversity, scale and pricing power,” said the Moody’s report, adding that it expects Indian companies to be interested in competing assets or drugs that come up for sale as a result of industry consolidation.

1) India weighs mandatory UCPMP to curb unfair pharma marketing practices:

India is considering making its voluntary Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) mandatory to curb unfair marketing practices by pharma companies, including providing incentives for doctors to prescribe their products.

A notification from India’s Department of Pharmaceuticals (DoP) issued in September says, “It has been decided that the UCPMP, also covering the medical devices industry, which was implemented with effect from January 1, 2015 for a period of six months and which was last extended up to June 30, 2016 is hereby extended till further orders.”

Earlier in July, India’s minister for chemicals and fertilizers, Ananth Kumar, said that that voluntary UCPMP was not yielding the expected results and that the government was contemplating making the code compulsory.

The latest move on UCPMP is an attempt to address a long-standing problem of pharma companies striking deals with local physicians, in which the latter prescribe products after getting commissions from the former. The practice is especially rampant in the case of chronic problems such as diabetes, heart disorders and asthma. Other freebies to influence doctors include sponsorship of doctors’ foreign trips in the name of continuing medical education (CME), sponsoring trips to medical conferences abroad, and organizing ‘free’ medical diagnosis camps in conjunction with the doctors.

In India, two laws govern the sale and promotion of drugs — the Drug and Magic Remedies (Objectionable Advertisements) Act, 1954, and the Sales Promotion Employees (Conditions of Service) Act, 1976 – neither of which spell out a proper policy on unethical practices.

Additionally, a section on Rebates and Commissions in the Medical Council of India (MCI’s) “Professional Conduct, Etiquette and Ethics, Regulations 2002” stipulates that “A physician shall not give, solicit, or receive nor shall he offer to give solicit or receive, any gift, gratuity, commission or bonus in consideration of or return for the referring, recommending or procuring of any patient for medical, surgical or other treatment. A physician shall not directly or indirectly, participate in or be a party to act of division, transference, assignment, subordination, rebating, splitting or refunding of any fee for medical, surgical or other treatment.”

Faced with rising instances of violations of these clauses, India’s ministry of chemicals and fertilizers in 2009 noted the need to address the issue of unethical promotion of medicines, in the interests of patients, as it would impact drug prices.

In December 2014, the government announced the UCPMP and directed the pharmaceutical industry to adopt it voluntarily and comply with it for a period of six months, beginning 01 January, 2015. The UCMP has since been extended four times, since the first deadline of June 2015.

Read the full report in BioWorld :

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