FICCI presents pharma wish list to the Union Minister of Health & Family Welfare

A high level FICCI delegation led by the president Sidharth Birla met the Union Health and Family Welfare Minister Dr Harsh Vardhan recently. FICCI recommended a blended approach towards universal health coverage (UHC), one that strengthens the links of social health insurance to healthcare providers (both public and private) but ties funding to performance.

“A new National Health Policy needs to be rolled out to support implementation of universal health coverage (UHC) over the next decade. To contain rising cost of healthcare, we also need to provide facilitating regulatory environment to promote innovative products and practices to make India a hub for medical technology”, said Sidharth Birla, FICCI, President.

“For reducing the disease burden, the Government should focus on investments in preventive and promotive health in light of the rapid demographic and epidemiological transition in the country; significant incentives need to be extended to the health insurance and healthcare industry to introduce products and services focused on prevention”, Birla further stated.

Birla also shared FICCI’s wish list for the new Government with Dr Harsh Vardhan, Union Health & Family Welfare Minister.

Dr A Didar Singh, Secretary General FICCI, Dr Narottam Puri, Chairman NABH and Advisor to FICCI Healthcare Services and Rakesh Sharma, Co-Chair, FICCI Forum on Medical Devices and Head, Regulatory Affairs, BD India accompanied Sidharth Birla to call on the Minister.

Create an ecosystem for spurring R&D and innovation
The global industry is highly research intensive and spend around 15 per cent turnover in R&D, however, in India it’s still low with less than two per cent spending. Although the Indian private players have increased investments in R&D, the focus is on the thriving generics business instead of new drug discovery. As a global player we need to remove this weakness in the system by

• Setting up a “National R&D Observatory” in India, which will provide technical support to establish a system to monitor R&D investments and pipelines and recognising the considerable gaps that exist
• Ensuring flow of funds by raising the weighted tax deduction from 200 -250 per cent  and extending it to clinical trials as well
• Extending exemption from excise/custom duties on raw materials, capital goods and diagnostic kits.
• Building synergy with industry and major government institutions and universities for technology transfer and intellectual property right for research and innovation
• Encouraging innovation on continuous basis in order to create a favourable environment for incubation of new and unique recombinant biologics that will address the three issues of affordability, availability and quality in overall healthcare scenario.

Create a common understanding of clinical trials (CTs) landscape in India

From 2010 onwards India has witnessed heightened activism and media sensationalism targeting clinical research resulting in a slew of new regulations. While these regulations have been well-intentioned, they have proved to be disastrous for clinical research in the country and the long-term future of pharmaceutical innovation in India. There is an urgent need to revive the sector to address the burden of existing and new diseases. This would include recasting of adverse regulations introduced in 2013-14. In this regard, we propose the following:

• A framework of internal operating procedures should be put in place for the efficient functioning of the regulatory authority in order to maintain a high level of documentation, probity, and transparency. The functioning of the regulatory authority should be subject to regular audits. Summary audit data in appropriate format should also be available in the public domain.
• The regulatory authority should function at a high measurable standard of customer service with regards to research applicants. This should include time-bound review and disposal of applications. Customer service metrics should be available in the public domain in a timely manner.
• The CDSCO should be strengthened through a comprehensive programme of up-gradation of qualifications, skills and experience of personnel dealing with the review of research applications within the regulatory authority.
• Several issues pertaining to BA-BE studies, compensation packages, long processing time due for approvals etc. needs to be streamlined for reviving Clinical Trials in the country.
• Create awareness amongst judiciary, media and civil societies in order to enable them to take informed decisions.

Foster the quality agenda for API manufacturing

Some of the recent events have brought forth the need for incentivising and promoting quality practices in the API manufacturing in India. We propose the following:

• Encourage development of innovative API technologies and promote indigenous
• manufacturing of APIs
• The existing Indian GMP (schedule M + guidelines) should meet the international standards
• The existing clusters in the sector need to have common facilities for testing etc.
• Expedite the setting up of mega parks and new clusters in the API segment with common facilities
• Focus capacity building endeavors for both regulators and manufacturers in India.

Issues related to Drug Price Control Order 2013
There is a lot of issues in implementation of DPCO 2013 and there is no clarity on inclusion of
different dosage and different delivery system in the NLEM list. Slow process of price approval of new drugs and retail and wholesale margins to trade etc. is also an issue. NLEM list is expected to be further expanded which will create conflicting situations for drug manufacturers, importers, marketers and retailers and potentially lead to lack of access of medicines to the community at large. We propose the following:

• Device different guidelines for biopharmaceuticals that involve formulations based on
• biological products from chemical drugs
• Exclude brands with less than one per cent market share from ceiling price calculation
• Apply price fixation formula only to products, dosages and strengths specified in Scheduled I o DPCO, 2013
• Revise trade margin for retailers to compensate loss under DPCO 2013
• Price implementation in 45 days of notification/order from prospective batches.

NPPA’s order no. S.O. 1157 (E) regarding fixing of ceiling prices for 12 formulations.
Dexamethasone and Gentamicin injections are being marketed in 2 ml (single dose vial) and
bigger vials of (multi dose) 10ml, 20ml and 30ml packs. The ceiling prices of these formulations have been worked out by averaging the prices of different packs to retailer (PTR) as per MAT value as on 30th September, 2013. Averaging prices of different packs to arrive at ceiling price for all packs would not be in the interest of the manufacturer as it will not only impact the reduction in the ceiling prices but will also cause loss to the industry and impact the availability of these formulations in the market as the manufacturer will be forced to discontinue these products due to negative/low margin.

• There is a need to reconsider the notification issued by NPPA and issue guidelines to calculate and notify separate ceiling prices for different packs in case of injections, liquids and ointments. This will also be in line with notification on fixation of prices on pro-rata basis as per DPCO, 1995 which was applicable to only tablets and capsules

Foreign Direct Investments (FDI)
Currently, India permits 100 per cent FDI in the pharma sector through automatic approval route in greenfield projects and on a case to case basis for brownfield projects. The DIPP had
sought reduction of FDI limit for brownfield pharma projects from 100 per cent to 49 per cent in “critical’’ areas as it feared that acquisition of Indian companies could vitally affect availability and affordability of generic (off-patent) medicines.

• We recommend that the Government should continue with the present policy on FDI in pharma (uncapped). The free market should be allowed to prevail.

Ecosystem for Biotechnology
Since biopharma sector is one of the largest components of the Indian biotech industry and the most promising, India needs to maximise its presence in this space. This sector invests substantially in innovative product development and clearly a lot of companies see more value in ramping up their service offerings even as they try to overcome the technological, financial and regulatory challenges. To help streamline the issues, we propose the following:

• Promote Biopharmaceutical clusters for comprehensive indigenous manufacturing of similar biologics and vaccines
• Revive export incentives/BTP Schemes for this sector to realise its full potential. Since, R&D in biotech, especially the Biopharma sector is highly capital intensive, export tax benefits are required to de-risk and fund original research. The increased number of BTP schemes would also ensure provision of financial and logistical support for establishment of biotechnology parks and pilot projects in various states

Over the Counter Drugs (OTC)
There is a need to have separate regulation for OTC sector as there is no legal recognition in
Drugs and Cosmetic Act, definition of OTC drugs and positive list of OTC medicines. (FICCI had submitted a Concept note on Over the Counter Drugs to the Drug Controller General of India as enclosed)

EP News Bureau- Mumbai