World is looking for affordable treatment through quality and safe generics to reduce their disease burden. Considering the consumption of generic medicines in US alone, almost 45% of population is taking made in India medicines. As the time is passing, US population is consuming made in India medicines since last many years having relief and helping them in active life.
Quality and safety are the major aspects of any medicine for every citizen of any country, as it is affecting human life. Every manufacturer takes efforts to ensure that the systems, processes and regulations of manufacturing country and of those where they are exporting.
The Indian pharmaceutical industry follows stringent quality standards set by global regulatory agencies. The generic drugs that we manufacture undergo rigorous procedures to ensure the same quality standards as that of originator drugs.
Bottle of lies:
A new book arrives and discusses a decade old quality issue of Indian Manufacturers which world takes notice, makes sensational news and tries to make it as if it has happened a few days back!
Really an amazing engagement of all stake holders of pharma all over the world!!
Indian manufacturers are providing quality generic drugs to the patients throughout the world. For Indian pharma, patient’s health and safety remains fundamental. We will continue our efforts towards making a positive difference in lives of patients in most need by providing safe, efficacious and quality drugs. In India, we have been following principle of affordability, accessibility and quality since ages, as India is World’s best pharmacy hub.
The inferences in the Book titled Bottle of Lies are back dated, fed on half-truths and draw on historic information of select cases. These are far from the present situation.
Wrongly created perception gap:
As this perception gap about India is created on a few select cases and also not quoting other cases of many countries, projects different view point about Indian generic formulations. There are three implications of this kind of creation of perception gap and which would affect more to Indian Pharma industry.
1. Creates bad opinion and bad business environment
As pharmaceuticals are a socio-political-economic issue and it affects every citizen of each country, media further projects wrong side of the country. Hence, everybody looks at pharmaceutical industry and the prices of medicine with a Jaundiced eye, whereas emergence of new diseases and million-dollar investment in creating solutions through new vaccines and medicines that goes unnoticed. As each country is trying to reduce its disease burden through selection of high quality, low cost generic medicines made in India on the contrary are serving almost all countries inclusive of US.
Once this perception gap is created and comes on the top in media with type, business environment becomes Doubting Thomas!
It hampers the Global industry dynamics.
2. Uncertainty turns away investment
Such gap which creates poor reputation hits companies where it hurts, which gets converted to stock prices. Investors shy away from such industries where uncertainty increases.
It is very difficult to prove or disprove, but it is a fact that gap in reputation leads to shying away from industrial sector.
3. Gap in reputation also repels talent
This is a long-term loss, whereby incoming talent to industry is repelled.
Almost similar, but not exactly same situation took away an opportunity of becoming world’s recognised hub of clinical trials few years before!
Bottle of facts:
1. India amongst top five pharmaceutical industry
Globally, Indian pharma has outperformed to improve public health outcomes, it accounts for 60 percent of global vaccine production. One in every three pills consumed in the United States is produced by an Indian generic’s manufacturer. In the UK, approximately 25% of the medicines used are made in India. India’s exports of generic drugs have also been growing at a very impressive rate of 24% per year for the last four years. Majority of exports is done to highly-regulated western markets. Even the cost of HIV/AIDS treatment has reduced to $400 per year from $12,000.
2. Indian Generics a boon to US Healthcare system
In last 10 years, US healthcare system has saved almost $2 trillion due to usage of generic drugs. Out of this, saving of $293 billion is from 2018, as per IQVIA Institute for Human Data Science.
This clearly indicates the efficiency of the Indian pharma sector in terms of quality and pricing.
3. Decreased OAI Inspection
According to USFDA data, wherever the issue was figured out during inspections, the Indian pharmaceutical organizations made remedial measures, and witnessed 4% inspection which is classified as Official Action Indicated (OAI) in 2018 as compared to 15% in 2017 indicating improvement in inspection outcomes. It means improvement in knowledge, quality culture; strength and capabilities of the Indian pharma have not been enormously improved.
4. Continuous training of drug inspectors to inspect total quality:
The All India Drug Control Officers Confederation had organized workshops to train drug inspectors across the country. The Central Drugs Standard Control Organization is trying to strengthen Indian regulators through training so that they can match international standards. Around 150 drug inspectors residing in western India were trained at Gandhinagar, so that they improvise inspection skills. Similarly, such workshops were held at different regions across the country.
5. Developed guidelines for data reliability, investigations, process validation and good documentation practices:
The Indian Pharmaceutical Alliance (IPA), consists of a group of leading Indian pharmaceutical companies such as Cipla, Lupin and Cadila Healthcare, had established a quality forum in May 2015 with the aim of total quality and not only compliance, with the help from McKinsey.
Let the battle be in between of Bottle of lies and Bottle of facts, but let’s not allow to degenerate or skew Indian pharmaceutical perception in the World.
1. Pharma conundrums & bottle of lies Ashok Kumar Madan, Health Express, June 11, 2019
2. India Emerges As Top Five Pharmaceuticals Markets Of The World; Business world, July 25, 2019
3. IPA Report-The Indian pharmaceutical industry – The way forward; June 2019
4. Pharmaceutical industry improving inspection skills for better compliance, Business Standard, April 8, 2018