Health insurance is an important aspect whereby pear like patient get subsidised and his affordability increases. Ministry of health, NITI Aayog, ayushman and their imperative should be given importance from implementation point of view.
In case of Regulation and competition as there are different bodies governing in different states integrating all these licenses could be great, imperative methods could be many in this process as digitization has made it transparent there could be supervision from the regulatory sight which can look at the anomalies and correct them.
In case of vertical arrangements in Healthcare services, providing an option to buy medications from outside for prescription generated in hospital could be additional boon to patient, however there should be no substitution on generic or branded generic name which is mentioned on prescription. There is a clinical experience with generic or branded generic medicines with healthcare providers hence that professional sanctity should be followed.
In case of quality perception behind proliferation of branded generics, as explained earlier will be injustice to those whom permission to manufacture and market generics is already given. Branded generics might be useful tool if there is process patent with the company to manufacture that particular generic which we used to have earlier in India before WTO stipulated increase on branded generics and can be permitted but no one drug one company one brand name could be insisted.
e-pharmacy if properly regulated the special mention of trade margins from patient point of view will be already taken care off. They would charge but they won’t be equivalent to services charges as much as trade margins. This particular mode of delivery will also obviate trade association self-regulation.
Trade margins are being suggested by DPCO and hence almost everybody in industry is following the same practice. This leads to almost 16%-20% margin on MRP for a pharmacist and 10% margin for stockist or distributors in this chain. In other words when MRP is Rs. 100 actual realisation price for company becomes Rs. 72 and overall margin Rs. 28 is given from MRP to middlemen!
Secondly, the manufacturing companies are licensed in each state in such a way that there is over capacity to manufacture medicines in India. Contract manufacturing wave has further taken ride and has saved the manufacturing cost, manufacturing charges which are also stipulated as per DPCO is the earning of contract manufacturers.
This overcapacity has rendered support to so many manufacturers or marketers who manufacture their products with these contract manufacturers. As a result we have plethora of generics available.
Recently Competition Commission of India released POLICY NOTE for affordable healthcare and mentions the first issue of high trade margins.
Considering this context, the policy note is talking about the trade margins stipulated by law or as a result of increased availability and high competition that those small manufacturers are offering high margins beyond stipulation on MRP.
2018 has demonstrated highest amount of private equity and venture capital investment in the country’s online pharmacy sector. The sector observed 10 deals of worth $140 million (Rs 8.8 billion) in 2018, as compared to five deals worth $37 million in 2017, according to data from Venture Intelligence, a research and analysis entity. Moreover, ResearchAndMarkets.com estimates the e-pharmacy market potential at over a billion dollars, with emergence of Amazon and Flipkart to get into this sector. The manpower supporting e-pharmacy today is around 20,000 with 1.5 million customers, according to a senior member of Digital Health Platform, the combination of online sellers.
For more Details Refer…
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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- Pharma conundrums & bottle of lies Ashok Kumar Madan, Health Express, June 11, 2019
- India Emerges As Top Five Pharmaceuticals Markets Of The World; Business world, July 25, 2019
- IPA Report-The Indian pharmaceutical industry – The way forward; June 2019
- Pharmaceutical industry improving inspection skills for better compliance, Business Standard, April 8, 2018
controlled by software to prevent, manage, or treat a medical disorder or disease. The components include a pill incorporated with a tracker and a wearable skin patch which transmits pharmacokinetic data of the drug to an app on a device such as the mobile phone. DTx can be used for optimizing the way cancer patients receive chemotherapy or diabetes patients adhere to their prescribed treatments.
Globally the market for DTx is at $0.17bn (2018) and is expected to reach $0.89bn by 2026 at a CAGR of 21.6%. The market in India is looking towards incorporating Digital Therapeutics (DTx) and Cipla is the frontrunner. Cipla has acquired stake in companies such as Wellthy Therapeutics and Brandmed which will enable Cipla to offer digital therapies and real time monitoring to address chronic diseases.
FSSAI has asked the FBO(Food Business Operator) to revalidate their existing and new products as per the notification dated on 23-12-2016.FBO are required to comply with the order by 1st Jan 2018.Scientific panel carefully considered the several representations received by stakeholders for their inclusion. Some ingredients have not been approved by FSSAI to be included in regulations due to-
- Likely to exhibit properties of drugs
- Inadequate data
- Safety issue
Since some of the issues are yet to resolve , FSSSAI made following timelines for FBO:
- Ingredients and additives approved by FSSAI for inclusion:
- According to annexure I, the ingredients/additives which are approved by FSSAI for inclusion are given a time till 30th June 2018 for their reformulation
- In case of new permissible limit, FBO are given time for the period of six months from the date of revised/new formulation.
- Ingredients not approved by FSSAI for the inclusion due to inadequate data:
- The FBOs have given time to submit the data within 4 weeks from the date of issuance. For non- compliance, products containing such ingredients are to be withdrawn from the market immediately.
- Meanwhile, As per Annexure II, FBO are allowed to continue the food business of existing products.
- Ingredients not approved by FSSAI for safety reasons:
- FBO are directed to discontinue food business and withdraw the products containing ingredients namely ‘fluoride’ and ‘Potato protein isolate.
- Ingredients not approved by FSSAI since exhibiting drug like properties :
- FBOs are directed to discontinue the food business of products carrying drug-like ingredients namely ‘Willow Bark Extract’, ‘Pyrol Quinoline Quinone’ and ‘Lemon Bam’.
- For products already manufactured/imported are permitted to be sold till 30th June, 2018.
- FBOs are allowed to sell the formulation containing mere combinations of vitamins and minerals only up to one RDA in dosage formats such tablets, capsules and syrups for the period of 6 months or till the further order, whichever is earlier.
- As per Annexure lll, with respect to FSDU, FBOs be taken under medical advice are allowed to sell their existing formulations containing vitamins and minerals in food for special dietary uses without referring to the energy value(Kcal/K) for period of six months or till further orders, whichever is earlier.