25 May 2015 | News | By Dr R K Sanghavi, Consultant, Pharma Neuromarketing & Regulatory
The twentieth century has seen remarkable gains in health. Average life expectancy in developing countries was only 40 years in C
For the general health of the Indians there is needed a balancing of:
1. Medicines: The country has devised a National List of Essential Medicines (NLEM) that endeavors to ensure availability of affordable drugs.
2. Medical Professionals: The Vision 2015 document of Medical Council of India (MCI) has determined a target of the doctor-population ratio of 1:1000 to be achieved by the year 2031 by. This ratio in effect means one doctor for every village!
3. Medical Facilities: The Vision 2015 expressed objective was to enhance the quality and standards of medical education and training in India by providing more colleges and offering more postgraduate courses.
4. Healthcare Manufacturers & Suppliers: The Pharma 2020 document revisited in 2014 projects the global pharmaceutical market to more than double to $1.3 trillion, with the E7 countries — Brazil, China, India, Indonesia, Mexico, Russia and Turkey — accounting around for one fifth of global pharmaceutical sales.
The last one year for pharma sector
Availability of all essential drugs and at affordable prices is envisaged to be ensured by 2 mechanisms:
Drug (Prices Control) Order (DPCO): Creating a dynamic NLEM enables the National Pharmaceutical Pricing Authority (NPPA) to declare any drug at any time as under DPCO.
Negative impact on industry: In view of continual prevalence of uncertainty on which medicines will fall under price control, planning of profitability and investments has become baseless with resultant inability to visualize long term mission.
Generic Drugs: The government is revisiting Jan Aushadhi scheme that was started to make available low-cost unbranded medicines to people through designated drug stores. Since the inception of scheme in 2008 only 176 Jan Aushadhi stores are opened across the country and only 96 are functional as on December 2014.
Negative impact on industry: In view of the thrust of providing all medicines, even non-essential, via this outlet the branded drugs’ existence is threatened. There is also feared shift in balance from Pharma-Dr to Pharma-Chemist with resultant tilt towards lesser stringent quality-conscious manufacturers.
The challenges faced by the manufacturers are on many fronts and the current year have shaken their very belief in long term sustenance – forget development & growth, of Pharma companies.
1. Fixed Dose Combinations (FDCs): The State-Licensing Authority (SLA) Approved FDCs prior to September 2012 were to be regularized by the central authority [Drugs Controller General (India)] [DCG(I)]. This exercise is all set to conclude in 2015 and it is feared that as many as 3000 FDCs (excluding their copycats which could be 4 times more) will see their demise. The repeated reasoning with concerned authority to reconsider their drastic action even after substantiating that these FDCs have been available since decades and safely and effectively prescribed by the medical professionals have fallen on deaf ears. The resultant implications for especially Micro Small and Medium Enterprises (MSME) sector are grave, and even larger companies will have to face a significant erosion in their top and bottom lines – a void which could be difficult to compensate.
2. New Drugs: In the last couple of years the new drugs approved by DCGI has trickled to approximately 50 every year compared with near 200 in yesteryears. This has stunted the growth of the sector and the same has not been addressed in the last one year inspite of glaring evidence and multiple representations.
3. Health Supplements: The Food Safety Standards Authority of India (FSSAI) has created unimaginable turmoil for health supplement manufacturers. They have created an unlawful, unacceptable system of product wise approval that is alien to the practices followed in even regulated markets. The result is that established, and safely consumed products (many since decades) are being rejected and Food Business Operators (FBOs) are predicting doomsday for the continuance of their operations.
The present government needs to shift focus from patient welfare to industry welfare. Without successful backward integration the end objective can never be achieved. The regulators and policy makers need to appoint unbiased industry experts on their panels and regulatory bodies to guide decisions for favoring win-win situation. Otherwise the objectives of healthy Indian can only remain a pipedream!