Government To Promote Pharma Industry To Set Up Manufacturing Base In Sick States

Mumbai, 23 Jan 2018: 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.  Pharmabiz