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Govt to promote pharma industry to set up manufacturing base in sick states: Union minister Ashwini Choubey
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Shardul Nautiyal, Mumbai
January 24 , 2018
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Union minister of state for health and family welfare Ashwini Kumar
Choubey appealed to the Indian pharma industry leaders to set up units
in sick states like Bihar, Jharkhand and Uttar Pradesh to gain more
productivity at lesser cost considering the fact that many skilled and
unskilled human resource migrate from northern region to manufacturing
hubs like Maharshtra, Gujarat and other industrial belts. If the
industry gets foothold in these regions, it will generate employment and
increase efficiency.
Speaking at the Indian Drug Manufacturers
Association (IDMA)'s 56th Annual Day celebrations on January 20, 2018,
the Minister added, “Indian pharma industry today caters to the
regulated and unregulated markets by supplying quality drugs and
government is considering to incentivise industry and API industry in
particular by helping them set up new manufacturing units through
providing loans at low interest rate and other tax incentives.”
Initiative
on reviving API industry by providing incentives to formulators to opt
for indigenous APIs, allowing control-free price to formulations made
with indigenous APIs, reduction in approval time for application from
Central and State regulators to 3 months, re-orienting DPCO to move from
price control to monitoring of drug prices were some of the major
submissions made by IDMA during the event under the theme of ’Indian
Pharmaceuticals – Nation’s Pride’.
To alleviate the national and
global disease burden, IDMA 56th Annual Day Celebrations theme also
underlined the fact that the World Health Organisation, after thoroughly
assessing India’s National Regulatory Agency (NRA) under the Ministry
of Health and Family Welfare and Central Drugs Standard Control
Organisation (CDSCO), declared them as ‘functional’ with a maturity
level of 4, i.e., in respect of 5 functions, and maturity level 3 in
respect of 4 functions as per currently evolved definitions.
These
levels are considered very high for a National Regulatory Agency that
ensures that products approved by them for public distribution are
evaluated properly and meet international standards of quality and
safety. Earlier, WHO had also assessed India’s vaccines regulatory
system and declared it as having “100% compliance”.
NITI Aayog
recently invited IDMA and other industry stakeholders to review Drug
Price Control Order (DPCO) and NLEM towards totally revamping DPCO and
pricing methodologies. According to IDMA officials, DPCO 2013 and the
National Pharma Pricing Policy 2012 are well considered policies for
taking care of drug availability and affordability by maintaining
control on essential medicines, at the same time allowing market forces
to determine prices and as such there is no need to change the policies.
This will ensure a fine balance between reasonable prices,
uninterrupted availability, administrative feasibility and future growth
and investment.
IDMA made the submission that there is however
need to relook at price fixing methods. For instance, with GST being
implemented, it would be better if MRP is considered instead of Price to
Stockist (PTS) or Price to Retailer (PTR). This will even out the
concept of Retail Margins as perceived in DPCO. It was also suggested
that DPCO should be delinked from Essential Commodities Act, as drugs
are available in abundance and there is no need for controlled
distribution.
It was also deliberated and recommended that
manufacturers which have revised Schedule M compliant units upgrade to
WHO GMP and those who are WHO GMP complaint should upgrade to US
FDA/EDQM compliance towards compliance and ease of doing business. DCGI
has allowed risk-based self-inspection of manufacturing units at a time
when Central Board of Excise and Custom (CBEC) has allowed electronic
self-sealing of containers by exporters, submitting of letter of
undertaking (LUT) once a year for export. Exports without the payment of
tax can be made only after filing a bond or letter of undertaking (LUT)
as applicable to the exporter.
Till about a decade ago, China
was trying to catch up with India in APIs. Today, with its Government’s
support, China has moved far ahead. IDMA made a submission for providing
a favourable environment through industry friendly policies
highlighting how Indian API industry can recover and move ahead to claim
rightful place as the source for quality APIs.
Bhupender Singh,
Chairman, NPPA, Dr. R. K. Vats, Additional Secretary, Health, Dr. G. N.
Singh, Drugs Controller General of India (DCGI), Dr. S. Eswara Reddy,
Joint Drugs Controller General (India), FarhodArziev, Ambassador
Extraordinary and Plenipotentiary of the Republic of Uzbekistan, Amit
Sadana, General Manager, AMESA IMS Health (now renamed as IQVIA), were
present in the event.
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