Indian pharma industry is moving forward in the bulk drugs sector which is why it becomes imperative for the government to identify key areas for backward integration in the bulk drugs sector. The Indian healthcare sector cannot afford monopoly going by the disease burden of 110 million mental health cases in the country, 80 million cardiac cases and 60 million each in diabetes and asthma. The situation is equally alarming with hepatitis C which stands at 50 million cases currently. These were some of the inferences drawn on the occasion of 54th annual celebrations of Indian Drugs Manufacturers Association (IDMA) in Mumbai recently.

Speaking to Pharmabiz on the sidelines of the occasion, chairman Cipla Ltd  Dr Y K Hamied said, “We cannot base our industry on the imports of intermediates. Ideas like in-licensing and respecting science by helping innovation through giving royalties to the inventors will make healthcare accessible to Indians.”

Another challenging area which needs intervention from the pharma industry is that pharma companies should make the doctors and pharmacists aware about rational usage of drugs to prevent antibiotic resistance or anti-microbial resistance. There is a need to introduce newer antibiotics and use of older antibiotics through new drug delivery systems, Dr Hamied further added.
 
Dr V K Subburaj, secretary, department of pharmaceuticals, K B Aggarwal, additional secretary, department of health, Sudhanshu Pandey, joint Secretary, department of commerce, Sudhansh Pant, joint secretary, department of pharmaceuticals, Dr Y K Hamied, chairman, Cipla Limited, Daara Patel, secretary-general, IDMA, past presidents, captains of industry and fellow members of IDMA were present on the occasion.
 
Said IDMA chairman S V Veeramani on the occasion, “I am happy to acknowledge the contribution of Dr Y K Hamied in revolutionising the fight against HIV and AIDS to make generic versions of life saving drugs easily accessible and affordable, thus saving the lives of millions of people globally and reiterating our theme of ‘Pharmaceuticals for Patient Benefit”.

The government appeared to be equally concerned about India’s overdependence on China for APIs and intermediates. To focus on the issues of the bulk drug industry, government declared the year 2015 as the ‘Year of Bulk Drugs’.

“The Indian pharmaceutical industry, more than any other industry, is achieving our Prime Minister’s call to “Make in India’, and the Indian generic medicines have been universally recognized for being synonymous with quality and reliability, at the same time being the most affordable. The industry also follows the Prime Minister’s other dictum “Zero Defect and Zero Effect”, he added.

IDMA has been interacting with various government departments and ministries on working out the missing links and strengthening the policy environment to address issues that could hinder pharma industry’s further development and growth. The industry faces a few unique problems, unlike other sectors in India. It is, even today, the most heavily regulated and controlled sector that impact ease of doing business. Some of these major causes for concern are overdependence on China and our declining bulk drug industry, issue of SLA-approved FDCs, uncertainty in continuation of PET bottles, NPPA’s interpretation in regulating prices, trace and track system for pharma packs for exports and domestic market, proposed hike in fees for registration and licenses etc. These issues unless addressed and resolved at the earliest may undermine the growth of the Indian pharma industry, both nationally and globally.

Chennai was recently devastated by floods due to heavy rainfall. Essential medicines were urgently required as also rehabilitation of flood affected people IDMA members from Tamil Nadu and all over India rose to the occasion whole-heartedly and immediately rushed medicines as required urgently in truckloads to the Tamil Nadu government.

The ministry of health and family welfare published a draft notification dated January 29, 2015 which proposes drastic increase in fees for registration for import and domestic manufacture.

“Though we appreciate the need to increase fees for imports of bulk drugs to protect the local industry, we are not in favour of any hike in fees for domestic manufacture of bulk drugs or formulations. The industry has matured and it is estimated that there are over 64,000 formulations with over 10,000 manufacturing units in the Indian market covering almost every therapeutic segment with about 10 to 200 brands per molecule. This has been possible due to the support provided by our government, especially to the small and medium enterprises. A steep increase in fees for domestic licenses will gravely affect the working of SMEs and drive them away from production leading to unnecessary hassles in availability of medicines,” Veeramani added.

He further concluded that the National List of Essential Medicines 2015 is released. We are sure that, as noted in the recommendations of the Katoch Committee, the revised NLEM 2015 has been prepared adhering to the basic principles of efficacy, safety, cost-effectiveness; consideration of diseases as public health problems in India. A total of 106 medicines have been added, and 70 medicines have been deleted to prepare NLEM 2015 which now contains a total of 376 medicines. We have requested the department of pharmaceuticals to consider the list for fixing or revision of prices after April 1, 2016 to avoid frequent changes in prices.