May 6, 2020 | General
As a practicing dentist for 23 years now, I have seen my fair share of success during what has been a promising time for dentistry in the last decade. The overall market size of the Indian dental industry was estimated to be approximately USD 2 billion in 2019. Investors have been pumping money into dental chains and specialist dental centers over the last few years. Every fifth ad on TV is for an oral healthcare product. Dental tourism accounted for about 10% of the total medical tourism and was projected to grow at 30% per annum. The India dental service market was expected to grow at a CAGR of 7.34% through 2025.
| What keeps me awake at night is not just the uncertainty looming over my own practice, but equally, the dark gloom that has descended on the future of the profession. |
However, this scenario has changed dramatically today with the coronavirus pandemic. According to the New York Times, dental surgeons are at the highest risk of contracting and transmitting the Coronavirus, alongside paramedics, nurses, and other healthcare workers. Agreeably, dental clinics across the country have been shut for over a month and a half since lockdown measures were announced, and for longer in Karnataka. Most of us who understand the ramifications of this pandemic are preparing to hold off reopening our clinics for at least a few more months – which translates into zero earnings, and consequently a very uncertain future for us and the staff at our clinics.
Here is a quick peek into the stark future of dental practice post CoVID-19. According to the DCI’s advisory released on 16th April 2020, dentists must now strictly follow all protocols to decontaminate, disinfect and sterilize at the clinics as prescribed, enabling us to treat a maximum of only 3 or 4 patients a day. Dentists and our assistants will now need to mandatorily use PPE suits, goggles, face shields, N95 FFP3 masks, surgical gloves and shoe covers, single use chair covers etc., and more for all procedures. With this, already exorbitant treatment costs will at least double, if not more. Informal checks suggest that nearly 80% of dental clinics at present don’t follow the most basic sterilization protocols. If some of these practitioners choose to compromise on the quality of PPE used or sanitation maintained in their clinics, the resulting impact to societal health will be catastrophic. Apart from the huge monetary investments required to continue safe dental practice, there is also the equally important issue of proper training and process management in following these protocols to ensure minimal risk to patients and dentists alike. The advisory also recommends only emergency dental services in the near future, further impacting the financial plight of dentists. When the lockdown measures do ease up finally, given the overall uncertainty in the economy, people will tend to put off any elective dental procedures as they are not covered under health insurance schemes, despite repeated appeals by dentists in the last decade.
Now for some math. India has over 2.7 lakh dentists registered with the Dental Council of India (DCI) according to the NHP 2018, and we have an average of 27,000 new dentists graduating every year. Unemployment of dentists in urban areas is a huge issue already with projections revealing a surplus of about one lakh dentists in the country today. Now, multiply this with the unemployment aftermath of CoVID-19. While there are no official statistics released in India on the impact of CoVID-19 on dentistry yet, a poll conducted by the American Dental Association says 46 percent of dentists indicated they would likely need to sell their practice or file for bankruptcy if the current situation continued beyond August 2020. I suspect the scenario would be the same in our country, if not worse.
| We need a balanced combination of an immediate fiscal impetus to jumpstart the industry again, and more long-term measures that will set it on its growth trajectory over the next two decades. |
CoVID-19 is threatening to reverse the growth trajectory and ring in the death knell on dentistry as a profession in India. There is a serious and immediate need for government intervention to help support and stabilize the dental industry. Call it an urgent requirement of CPR for dentistry if you will.
Here are 5 ways the government can address the malady affecting the dental industry today.
- Inject fiscal support for the fledging industry over the next two years: This could be on subsidized provision of quality PPE, sanitization equipment and material, and reduction on import duty levied on expensive dental equipment to ensure dentists maintain adequate hygiene standards and aseptic protocols necessary for safe practicing. What would also help is perhaps an easing of taxes for the industry for the next two years, interest-free loans and top-ups. Equally importantly, there is a need for a government led business insurance plan for dentists and their practicing staff protecting them for losses and health concerns arising as a result of exposure to the viral strain or other pandemics. In parallel, we must bring dental treatment under insurance coverage for the general public. Combined with this, the government must also actively look into setting up ancillary industries that can cater to the requirements of the healthcare industry, boosting employment locally and reducing our dependence on medical imports.
- Move away from a compartmentalized approach to oral health: Dentistry has long been the forgotten, poor cousin amongst healthcare practitioners and consequently, in public perception as well. However oral health is the window to general health – with more than 120 medical conditions that can be diagnosed through an examination of the oral cavity. Regular preventive oral checkups can reduce both the risk of diseases and the cost of oral treatment which can otherwise be very expensive. The government should ensure every government hospital and primary healthcare center across the country has a dedicated oral healthcare department – this will also provide employment to the thousands of dental graduates in the country who can train to pick up expertise and practical knowledge on the field that is currently lacking.
- Restructure dental education and bring it under general medicine: I will say this one like it is. Dentistry has mostly been an afterthought profession for aspirants of general medicine who did not quite make the cut with their entrance scores. As a result, there is general apathy towards dentists both within the medical community and in the larger healthcare segment. Combined with this, the standards of dental education are abysmally low in the country. Concepts taught in dental schools haven’t changed in the last 3 or 4 decades while what is practiced on the field is vastly different, aided by technological and scientific advancements. Dental graduates are unable to diagnose basic general health conditions or read ECG / CT scan reports. Pharmacology likewise has become very advanced while dental grads fresh off the campus struggle with basic prescription details. The science of dentistry is fast disappearing and what colleges are churning out are mere technicians practicing age old procedures that are no longer relevant.
The standards of dental education must improve for long term gains. Dentistry should be brought under general medicine where students earn a primary MBBS degree and then specialize in dental sciences at the post-graduate level. The government should also relook at existing teaching licenses for colleges in the country and weed out those who do not meet the requisite standards in theory and practical exposure. This will help address 3 issues plaguing the industry currently – Dentistry will no longer be a poor substitute option for MBBS reject candidates, and quality of service will no longer be impacted. Dental graduates will be better equipped to study the field as a holistic science, understand the co-dependence of dental health and overall health, and will be better prepared in dealing with any medical emergencies in their practice, resulting in better patient care. Third, in the event of national health emergencies such as the CoVID-19 pandemic, the country will have a larger, better equipped pool of medical professionals who can provide basic health care services at scale.
- Encourage public – private partnerships: Dentistry and the medical field in general are lacking innovation and a healthy competitive spirit at the graduate level. There is a pressing need for privatization and globalization of dentistry and medicine, which will bring in a healthy dose of aggressiveness, agility and exposure to cutting-edge technology and the latest research – opening up opportunities and access to knowledge – all ultimately benefiting the practitioners, the industry and patient care. The government must encourage private partnerships within the country and with reputed universities abroad. They can well counter any perceived reduction in quality of education by formulating appropriate guidelines to be strictly enforced by regulatory bodies that govern these alliances.
- Periodic assessment and mandatory skills upgradation: The dental industry must have an active regulatory authority that periodically assesses all dental clinics across various parameters including expertise and exposure to the latest in dental practices and hygienic practicing conditions. This could be implemented through a mandatory skills upgradation program that is linked to license renewal for dentists every two years, after a thorough assessment.
The road to recovery will be painful and prolonged. But this health emergency won’t be the last one. And we must be better prepared for what is likely to come next and equip the dental fraternity and industry to overcome the next hurdle. The above measures will not only help us produce dentists and medical professionals who are competent and confident in tackling health issues in the new decade, they will also bring in much needed investment and revenue injection into healthcare. This in turn will increase employment in allied fields including dental technicians, assistants, lab specialists, etc. It will also provide an impetus to ancillary manufacturing industries that will further generate employment and revenue in the country, nudging us back onto the growth trajectory of being a leading dental and healthcare destination globally.
Author: Dr. Srivats Bharadwaj, MDS, Chairman & CEO, Vatsalya Dental
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Apr 20, 2020 | Indian Patents Act 1970, IPR & Business
Parle-G is a leading biscuit brand under Parle Products for biscuits and confectionary items. With a worldwide presence, Parle has carved out a place for itself in the biscuit business with value-for-money products, widespread availability, consistent taste and a very long presence in the business.
Foundation
Founded in 1929 by Mohanlal Dayal Chauhan, House of Parle grew and gained popularity as a trusted biscuit and confectionary company in India, eventually gaining worldwide presence. It got its name from the location of the first factory in Vile Parle (then Irla Parla) Bombay, Maharashtra.
The founder, Mr. Mohanlal Dayal, was a part of the Swadeshi movement and Parle Products was started as an attempt to have a homegrown biscuit and confectionary company to serve Indians. At a time when biscuits were considered to be luxury goods and were imported from Britain, only the rich could afford it. Parle Products started with the aim of making confectioneries and biscuits available to all classes of the Indian society, rich and poor alike. Parle-G or then known as Parle Gluco was born in 1938 and thrived on being affordable to all and was marketed as healthy biscuits available to all.
As the years passed, Parle Products introduced various products for Indian markets, understanding the demands and psyche of their consumers. This included a variety of biscuits, candies and other snacks. In 1947, when India gained independence, there was a shortage of wheat supply. However, this did not stop Parle from producing India’s very own biscuits. There was a temporary shift to Barley biscuits and their ad campaign focused on encouraging people to buy barley biscuits instead.
Market Success
Parle-G has created its brand value and brand trust among consumers over the past 90 odd years. Many factors have played important roles in achieving the success the brand enjoys today, with a worldwide consumer base and being the top-selling biscuit brand in India and the World. Some of these include the following:
- Advertising
Starting from printed advertisements in the pre-independence era to having an active social media presence today, Parle-G’s advertising has been one long journey transforming a local confectionery product to the biscuit brand that India loves. But in all these years, while Parle Gluco went on to become Parle-G, the company’s positioning is the one thing that still holds true to the brand even today. Right from its packaging to its pricing, Parle-G has always appealed to the masses of India. Sometimes by harping on the emotion of nostalgia and most times constantly evolving in their advertising insights to stay relevant to their audience. Parle-G’s 2018 campaign – ‘Aaj ke digital geniuses ke liye’ is the perfect example of that.
- Pricing
Low and affordable prices was the principle behind the inception of Parle Products during pre-Independence India and has since been carried forward as the distinguishing factor for Parle-G. Not only is the brand popular among the more affluent, it is also the most popular biscuit brand amongst the impoverished because of its affordable pricing. According to Kamal Kapadia, who worked at Parle for 32 years and left as CEO, Bengaluru project, this has been possible because “it had everything in-house, from packaging to procurement. And, the owners were hands-on.”[1]
- Packaging
Over the long period of time that Parle-G has existed, it has maintained a simplistic yet differentiating packaging, with the photo of a young girl on all Parle-G packaging. This has helped the brand create a unique identity and a visual association of the brand with the product. This in turn helps the brand stand out and have a loyal consumer base.
- Product
Parle Products have maintained their quality, including Parle-G, with consistency in taste and by marketing the product as a healthy glucose biscuit. Even though it is manufactured on a very large scale and in different factories across the country, Parle-G has maintained its taste over the years. The brand boasted of having created the country’s largest oven between 1946-50.[2]
From Parle Gluco to Parle-G
During its inception in 1939, Parle-G was called Parle Gluco because the brand sold very popular glucose biscuits. For a very long time, Parle Products sold these biscuits under the name of Parle Gluco and enjoyed exclusivity of this name. However, “Gluco”, which stood for “Glucose” was of such a nature that it belonged to the public at large for common use and could not be registered as a trademark. Hence, it was a “publici juris trademark” and the competition for Parle Gluco increased since many other companies started using “Gluco” to sell their brand of glucose biscuits.
In 1982, a rebranding and reimaging of Parle Gluco biscuits by Everest Brand Solutions gave birth to the very popular “Parle-G” biscuits, which was a trademark of the glucose biscuits sold by Parle Products. This helped secure the consumer base and develop consumer loyalty towards Parle Products by discarding the use of a word which could not be used exclusively by the company.
Breaking Sales Records during the Covid-19 Pandemic
Although Parle-G has been the favourite biscuit brand of the country for a very long time, the market has seen the growth of many other brands in the last few years. However, the onset of the Coronavirus Pandemic and the subsequent lockdowns brought about an interesting spike in the sales of the biscuits. At a time when packaged food has emerged as the go-to grocery option and people have found themselves indoors for a solid few months, snack consumption has increased considerably. Other than this, those financially weaker have also resorted to these cheaper yet healthy biscuits during these unprecedented times.
For the brand, March, April & May have been their best months in over eight decades. “We’ve grown our overall market share by nearly 5%… And 80– 90% of this growth has come from the Parle-G sales. This is unprecedented,” said Mayank Shah, category head at Parle Products.[3]
Therefore, by catering to a variety of needs during a pandemic and by maintaining steady production of Parle-G biscuits, it has seen the highest ever sales during the country-wide lockdown.
By Ria Mishra
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[1] https://www.business-standard.com/article/management/40-years-ago-and-now-parle-g-tackled-crunch-with-price-and-reach-115022601254_1.html
[2] http://www.parleproducts.com/timeline
[3] https://economictimes.indiatimes.com/industry/cons-products/fmcg/82-year-old-parle-g-books-best-sales-in-covid-times/articleshow/76275237.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst
Apr 19, 2020 | Indian Patents Act 1970, IPR & Business, Startups
Recently in June 2021, Sun Pharmaceutical Industries Ltd, Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, settled a patent litigation with Celgene Corp, a subsidiary of Bristol Myers Squibb. This litigation was regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US by Sun Pharma.
Revlimid (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma and is a single agent which is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. It is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Lenalidomide is on the World Health Organization’s List of Essential Medicines.
Abbreviated New Drug Application (ANDA) is an application that is filed at FDA to get approval for generic drug where the innovator drug is already approved. Typically, generic drug is equivalent to an innovator drug product in terms of dosage, form, strength, route of administration, quality, performance, characteristics and intended use. All approved products, both innovator and generic are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
ANDA application passes through 4 levels of certifications where paragraph IV certification is very critical. It requires applicant to establish that the generic drug for which ANDA is filed does not infringe any existing patent rights of the third parties. To understand patent infringement, it is important to know rights of a patent holder. In a given jurisdiction where patent is granted, a patent holder has right to prevent third parties from making, using, selling, offering for sale and even importing the patented product. Violation of any of the rights of the patent holder or patentee is called as infringement.
In this case, Celgene had a patent on Revlimid and upon ANDA filing by Sun Pharma, Celgene filed a lawsuit for patent infringement against Sun Pharma. Licensing is one of the popular ways, the companies adopt to settle the patent litigation in exchange of royalty payment. The word “license” means “permission”, which may be granted by the patent holder on certain terms and condition for a specific period of time by executing an exclusive or non-exclusive license agreement. In this case, Celgene agreed to grant license to Sun Pharma, for a specific amount of money to be paid by Sun Pharma as royalty, to manufacture and sell the drug, subject to the U.S. Food and Drug Administration approval. By providing license, Celgene would allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the U.S. from Jan. 31, 2026.
Before this case between Celgene and Sun Pharma, other Indian companies, Cipla Ltd., Natco Pharma Ltd., Cadila Healthcare Limited and Dr. Reddy’s Laboratories Ltd. and the U.S.-based Alvogen had settled patent litigations for Revlimid with Celgene. Celgene granted patent license to all these companies, required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning after January 31, 2026. However, these company’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.
By Bindu Sharma and Deepa ES
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Apr 18, 2020 | Indian Patents Act 1970, IPR & Business, Patent, Startups
After working hard on the new idea, investing money, resources, it’s time to fulfil the dreams, set-up new business, bring new product in the market. IP protection is an important step to secure innovation to prevent others from copying it. Is there anything else that is required to be done much before it? Following are the most crucial issues to be considered by an inventor to help him in enhancing quality of research and file the patent application in a cost-effective manner:
Prior art search: Get a thorough prior art search done right in the beginning when you conceive a new idea. The scope of the search should not be limited to the granted patents, but the published patent applications and paper publication should also be searched. The search shall be done globally using various paid or unpaid databases to identify the closest and the most relevant patents/patent application that would help you to assess the novelty of the invention. Prior art search also is helpful in drafting of the patent specification. Prior art search is an essential and crucial step to give shape to your idea and hence it’s a good idea to take professional help to get the search done.
Maintain confidentiality: Inventors often are extremely passionate and enthusiastic about their invention. Having invented something feels great and one feels like disclosing it to the world. But stop! It is strictly essential to maintain strict confidentiality of the invention till the patent application is filed. One of the critical requirements of getting a patent is that invention shall be novel on the date of filing. Hence, never disclose, publish or make your invention available to public till you file a patent application for the same. Additionally, do have an NDA (Non-Disclosure Agreement) with your attorney as well for the same before initiating discussion on filing patent application. A classic example is when Archimedes solved the problem of checking the purity of a gold crown without damaging the crown. While taking a bath, he noticed that the level of the water in the tub rose as he got in and realized that this effect could be used to determine the volume of the crown. Archimedes then ran in the street naked, so excited by his discovery that he had forgotten to dress, crying “Eureka!”.
Documentation: Documentation of an invention is extremely critical. Stepwise documentations shall be done and the novel features of the invention, existing technical problem which your invention overcomes, how your invention works shall be highlighted. Explain the process or the product with drawing and\or flow diagrams. Thorough understanding of the invention by your attorney is necessary. Don’t get lazy to fill the invention disclosure form if given by your attorney in order to describe the invention systematically. Consider the cost: Understand why and in which county (ies) or jurisdiction (s) you want to file a patent application. Choosing to file provisional or complete application, PCT application or convention application or filing in India based on your requirements can really help you to manage your finances and to identify the timelines. Spend some time with your attorney to understand the procedure to work on the most cost-effective package.
Explore options other than patent: Depending upon kind of product, it is advisable to explore other option for protection of the innovation in the form of copyrights, design or trademark. Being an inventor requires tremendous amount of effort and taking invention in right direction, in right manner is imperative to protect it appropriately and to reap the benefits.
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Nov 27, 2019 | Patent
In order to file a patent application outside India, for Indian residents, it is required to seek permission from Indian Patent Office and this permission is called as Foreign Filing Permission or Foreign Filing License. According to Section 39 of the Indian Patent Act, 1970, if an applicant is a resident of India but is interested in filing a patent application in a foreign country, the applicant has the below-mentioned options:
Option 1: Filing an application at the Indian Patent Office under section 7 and wait for 6 weeks before filing in the foreign county of their choice including PCT. If there are any issues regarding the invention or its subject matter, the Controller is expected to provide necessary directions, including secrecy directions, within 6 weeks. In the absence of any such directions within this timeframe, the applicant is free to file applications outside India.
Option 2: Obtain permission from Indian Patent Office to file patent application directly in the foreign country without filing an application in India.
This permission is known as foreign filing permission and is required to be submitted by the applicant to the Indian patent office on Form 25, “On application for permission for applying patent outside India under section 39 and rule 71(1)”. The fee for submitting Form 25 is INR 1600 for natural persons, start-ups, small entities or educational institutions and INR 8000 for large entities. There is a 10% additional fee which is applicable for filing in physical mode. The details required for such a form include applicant details, inventor details, and the reason for which the applicant is seeking the foreign filing license. Along with the Form 25, the applicant is required to submit the details of the invention in the form of a complete specification and the drawings enabling the Controller to review the invention in light of subject matter relevant to defence purpose or atomic energy, if any, which the applicant is planning to file in the foreign country.
The Controller usually takes approximately 21 days of time to examine and provide his approval for the request. However, if the invention is relevant for defence purposes or related to atomic energy, the Controller will not grant permission to file patent in a foreign country without the prior consent of the Central Government of India. In case of inventions relating to defence or atomic energy, a period of 21 days shall be counted from the date of the receipt of clarification/consent from the central government.
It is interesting to note that if the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permission to file patent in foreign country without the prior consent of the Central Government. This section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.
Non-compliance with provision of Section 39
As per section 40 of The Patents Act, an application shall be deemed abandoned if contravention of section 39 is found.
Further, as per section 118, violation of directions given under section 35 or contravention of section 39 may result in imprisonment for 2 years or payment of a fine or both.
Conclusion
If the applicant is a resident of India and wishes to file an application in a foreign country, the applicant can either file the application in India and wait for 6 weeks to subsequently file in the required foreign country or the applicant can take a Foreign Filing permission from Indian Patent Office and file directly at the respective foreign country without filing in India.
Author: Dharini Dinesh
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