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Balancing PATENTS & Affordable DRUGS

Pharma Sector in India is caught in the debate over the enforcement of Intellectual Property Rights (IPR) and access to affordable medicines. Affordable drugs are necessary and is a matter of great concern for the healthcare system. There is a need to refine the Drug policy in India in the light of growing concerns about patent filing in the pharma sector and access to cheap medicines.

Enforcement of Intellectual Property Rights encourages companies to invest in research and development. Most companies invest in research and development so that they can reap profits from the product developed. Patenting the product or process ensures that others do not replicate the concerned product to gain a share of the potential profits. But the critics of enforcement of intellectual property rights in the pharma sector argue that patents encourage monopolies. The pharmaceutical companies who patent drugs can sell those drugs at quite high prices because of no competition involved in the marketing of the drug.

The incomplete understanding of intellectual property rights (IPRs) is the real issue that India’s drug industry is facing. Currently, only 5% of medicines used in India are said to be patent-protected. Breakthrough therapies are being developed in the world but why these therapies are not made available to India but are being introduced in other countries?

It is observed that the new drugs and therapies encounter delay in marketing approval in India despite their global launch. Moreover the new drugs that are launched in India are produced and sold as generic versions by Indian manufacturers within one year of their introduction. Generic medicines are the copies of brand name counterparts of drugs originally developed by other companies. The rapid appearance of generic versions of medicines and delays in marketing approval display a lack of faith in the patent regime.

Patents are important in innovative sectors like pharmaceutical industry as they provide incentives for companies to invest in those sectors. Investment in innovation, research and development is an essential component of supporting an innovative and enterprising economy.

In order to link medical innovation with affordable treatment  a supportive role by the Government is required. The government should design a price-control mechanism without tampering the grant of patents. The government should deploy tools to reduce uncertainty in Intellectual Property Rights and to build an ecosystem that promotes medical innovation. We must achieve a balance between the current and future needs of patients and the timely introduction of existing and new pharmaceutical drugs.

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Top medical disruptors of 2018

As per a famous Indian Proverb :

“Jaan hai to Jahan Hai”. (If) there’s life, then there’s the world.

If there’s anything worth using technology, it’s for keeping ourselves alive and healthy. With the development in technology, healthcare in India is showing a gradual progress. The medical industry has undoubtedly benefited hugely from technological advancements and is the most promising market for businesses across the globe. There are millions of opportunities to create an evolving business by tackling the major medical challenges of the mass population. Numerous startups and companies are looking to HealthTech to offer life-changing products that harness innovation to enhance quality of care. But what are the latest developments in the works, and which companies are fuelling them?

1). Scalp cooling to prevent chemotherapy-related hair loss

Chemotherapy-induced temporary hair loss is one of the most common and distressing side-effects of cancer therapy. The Scalp cooling system has the potential to reduce cellular uptake of chemotherapy agents and decrease the chances of hair follicles experiencing damage from chemotherapy. During the clinical trial, 50.5% of patients were able to preserve their hair using the scalp cooling system. The system was FDA-approved in May 2017 and is starting to become available in hospitals nationwide.

US 9101463

Title: Head cooler

Assignee: Dignitana AB

Publication Date: 11 Aug 2015

Abstract: A head cooler (10) comprises a thermal exchange cap (11) and an outer insulating cover (12) to be arranged on a patient’s head. The cap (11) has a channel system (31, 32) for a cooling fluid forming an inside heat exchange surface to be applied on said head for cooling the head. The thermal exchange cap (11, 60) is adjustable and/or adaptable to compensate for a discrepancy in shape and size between the inside surface of the head cooler (10) and the head. The head cooler (10) may further comprise an eyebrow cooler (140) for cooling the area of the eyebrows. The head cooler (140) is used in medicine. A method for preventing hair loss of a patient is provided by arranging the head cooler (10) on the head of said patient.

2. Centralized medical monitoring system

In a hospital health care monitoring system it is necessary to constantly monitor the patient’s physiological parameters

US 9659149

Title: Medical monitoring system based on sound analysis in a medical environment


Publication Date: 23 May 2017

Abstract: The invention relates to a medical monitoring system (100) based on sound analysis in a medical environment. A sound level analyzer (SLA, 10) is capable of providing an indicator for perceived levels of sound from a number of sound events, and a data storage modality (DSM, 20) is receiving and storing said indicator for perceived levels of sound and also corresponding information from an associated patient monitoring system (PMS, 60) handling information indicative of a physical and/or mental condition of a patient under influence by sound. A sound event analyzer (SEA, 30) is further being arranged for performing, within a defined time window, an overall sound analysis (ANA, 50) related to physical and/or mental condition of the patient that may be influenced by sound in order to assist or supervise medical personal with respect to the acoustic environment.

3. Enhanced recovery after surgery

Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery.

US 9283263

Title: Compositions and methods for enhancing recovery after surgery or an athletic performance

Assignee: Top Doctors Labs (Fairfield, CA, US)

Publication Date: 15 March 2016

Abstract: The invention provides compositions and dosage forms, e.g., in the form of dietary supplements, such as pills, tablets, beverages, or gels, that enhance recovery after surgery or after an athletic performance. An exemplary composition or dosage form comprises about 5000 IU of vitamin A, about 15 mg of vitamin B1, about 34 mg of vitamin B2, about 25 mg of vitamin B3, about 50 mg of vitamin B5, about 20 mg of vitamin B6, about 90 μg of vitamin B12, about 300 mg of vitamin C, about 500 IU of vitamin D, about 60 IU of vitamin E, about 160 μg of vitamin K1, about 5 μg of vitamin K2, about 300 μg of biotin, about 400 μg of folate, about 30 μg of PABA, about 1 mg of boron, about 200 μg of chromium, about 500 μg of copper, about 150 mg of magnesium, about 5 μg of manganese, about 100 μg of molybdenum, about 135 μg of selenium, about 100 μg of vanadium, about 20 mg of zinc, about 150 μg of iodine, about 1.2 mg of pomegranate extract, about 250 mg of bromelain, and about 250 mg of quercetin. Methods for using the compositions and dosage forms for enhancing recovery after surgery or after an athletic performance are also provided herein. The invention also provides kits comprising a composition or dosage form described herein.

4. Targeted breast cancer therapies

Targeted cancer therapies target specific characteristics of cancer cells, or gene mutations that result in tumor development. Targeted therapies as the name specifies specifically target cancer cells and are less likely to harm normal and healthy cells as compared to chemotherapy.

US 9624549

Title: Stable gene targets in breast cancer and use thereof for optimizing therapy

Assignee: Cytognomix Inc. (London, Ontario, CA)

Publication Date: 18 April 2017

Abstract: A method for determining genes in breast cancer that are stable in copy number, expression and sequence in tumors from nearly all patients. Certain stable genes are targets of standard chemotherapy. The effectiveness of therapies that act upon these targets depends on maintaining the stability and integrity of these genes in tumors. Mutations in these targets result in poor response to therapies that target these gene products. In the instant invention, ordinarily stable gene targets are characterized as either normal or mutant for the purpose of determining whether to include or exclude particular drugs as potential treatments.

US 9285370

Title: ADAM22 for use as a prognostic variable, and target for therapy, of a metastatic breast cancer disease

Assignee: Royal College of Surgeons in Ireland (Dublin, IE)

Publication Date: 15 March 2016

Abstract: A method of diagnosing metastatic potential of a breast cancer in an individual with breast cancer is described. The method comprises a step of assaying a breast cancer tumor sample from the patient for expression of A Disintegrin and Metalloproteinase 22, (ADAM22), wherein expression of ADAM22 correlates with increased potential for metastasis compared with a patient who is ADAM22 negative. The invention also describes an agent for use in the treatment of metastatic breast cancer in a patient, in which the agent is selected from leucine-rich, glioma-inactivated protein 1 (LGI1) protein (SEQ ID NO:1) and an LGI1 peptide mimic capable of mimicking the ADAM22 binding activity of LGI1 by binding to the LGI1 binding domain of ADAM22 (SEQ ID NO: 4) and which is capable of inhibiting migration of endocrine resistant breast cancer cells.

Next-generation vaccine platform

It is expected that the medical industry will be seeing an upgrade to the entire vaccine platform to expedite new vaccines while also creating new ways of delivering vaccines.

US 9327026

Title: Multivalent breast cancer vaccine

Assignee: The Cleveland Clinic Foundation (Cleveland, OH, US)

Publication Date: 3 May 2016

Abstract: Compositions and methods for immunization against human breast cancer are disclosed. In one embodiment the multivalent antigenic composition is provided comprising immunogenic polypeptides selected from the group consisting of human α-lactalbumin, αS1 casein, β-casein and κ-casein.

US 9328149

Title: Mutated and bacteriophage T4 nanoparticle arrayed F1-V immunogens from Yersinia pestis as next generation plague vaccines

Assignee: The Catholic University of America (Washington, DC, US)

Publication Date: 3 May 2016

Abstract: Techniques from two basic approaches, structure-based immunogen design and phage T4 nanoparticle delivery, are developed to construct new plague vaccines. The NH2-terminal β-strand of F1 of Yersinia pestis is transplanted to the COOH-terminus of F1 of Yersinia pestis and the NH2-terminus sequence flanking the β-strand of F1 of Yersinia pestis is duplicated to eliminate polymerization but to retain the T cell epitopes. The mutated F1 is fused to the V antigen of Yersinia pestis to thereby form a fusion protein F1mut-V mutant, which produces a completely soluble monomer. The fusion protein F1 mut-V is then arrayed on phage T4 nanoparticles via a small outer capsid protein, Soc, from a T4 phage or a T4-related phage. Both the soluble and T4 decorated F1mut-V provided approximately 100% protection to mice and rats against pneumonic plague evoked by high doses of Yersinia pestis CO92.

6. The emergence of distance health

Physicians are working toward a goal of being able to provide healthcare from the comfort of a patient’s home. This means bringing monitoring devices into the homes and the ability to have a physician tell a patient the type of treatment they need to go through for certain conditions without having to go into the doctor’s office.

US 9208287

Title: System and method for remote tele-health services

Assignee: VIDEOKALL, INC. (Potomac, MD, US)

Publication Date: 8 Dec 2015

Abstract: A tele-health services cabin includes a plurality of vital signs monitoring devices, a cabin management unit, and videoconferencing hardware via which a remote practitioner in a remote medical call center videoconferences with a patient in the cabin to diagnose symptoms of the patient. The cabin management unit includes a processor that controls the cabin, a data input at which patient data is provided from the vital signs monitoring devices, and a transmitter connectable to a communication link for bi-directional communication between the cabin management unit and the medical call center, where the transmitter transmits the patient data to the medical call center. The tele-health services cabin may include a patient chair including a motorized seat back and at least one sensor encapsulated in the seat back. The tele-health services cabin may include a hands-free medical device station. The tele-health services cabin may include an automatic cleaning system.

7. The LDL cholesterol lowering drugs

LDL cholesterol lowering drugs are expected to be disruptors in the next year. The new drugs are expected to lower cholesterol to unprecedented levels.

US 8951514

Title: Statin and omega 3 fatty acids for reduction of apolipoprotein-B levels

Assignee: Pivotal Therapeutics Inc. (Woodbridge, Ontario, CA)

Publication Date: 10 Feb 2015

Abstract: A composition and a method of treatment utilizing a combination of statins (or HMG-CoA reductase inhibitors), a class of drug used to lower cholesterol levels by inhibiting the enzyme HMG-CoA reductase, with mixtures of an omega-3 fatty acid formulation containing about 90% or more omega 3 fatty acids by weight including a combination of Eicosapentaenoic acid (EPA), Docosapentaenoic acid (DPA) and Docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 5.7 to 6.3, wherein the sum of the EPA, DHA and DPA represent about 82% by weight of the total formulation and about 92% of the total omega 3 fatty acid content of the composition are taught.

US 9688630

Title: 3,3′-disubstituted indolines as inhibitors of cholesterol ester transfer protein

Assignee: Merck Sharp & Dohme Corp. (Rahway, NJ, US)

Publication Date: 27 June 2017

Abstract: 3,3′-Disubstituted indoline compounds, including pharmaceutically acceptable salts of the compounds, are CETP inhibitors and are useful for raising HDL-cholesterol, reducing LDL-cholesterol, and for treating or preventing atherosclerosis.

8. Hybrid closed-loop insulin delivery system

In 2016, the FDA approved the first hybrid closed-loop insulin delivery system. The system is designed to help manage Type 1 diabetes. It is a fully automated insulin delivery system that connects a continuous glucose monitor with an insulin pump, eliminating the need for people with diabetes having to test and manage their insulin levels themselves.

US 9795737

Title: Method and system for closed-loop control of an artificial pancreas

Assignee: Animas Corporation (West Chester, PA, US)

Publication Date: 24 Oct 2017

Abstract: Methods and systems for controlling an insulin pump in response to glucose measurements are responsive to a base insulin delivery profile and a temporary insulin delivery profile. These can be used, e.g., to control blood glucose level of a subject using a continuous glucose monitor and an insulin infusion pump. During a selected time range, an insulin amount for the pump to supply is determined using the temporary insulin delivery profile. Outside that time range, the insulin amount is determined using the base insulin delivery profile. The temporary insulin delivery profile can specify an exact amount to be supplied (a “hard” profile), a nominal amount to be supplied if doing so does not drive glucose out of a desired zone (“soft”), or a soft profile with a minimum amount of insulin to be delivered (“semi-soft”).

how to patent a business idea in india how to legally protect a business idea


Pneumococcal disease is a serious infection caused by a bacteria.
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Prevnar 13®”- Pfizer’s pneumococcal conjugate vaccine (PCV) Patent in India Case Study

Prevnar 13®”- Pfizer’s pneumococcal conjugate vaccine (PCV) Patent in India Case Study

Pneumonia is an acute respiratory infection which affects the lungs. It causes difficulty in breathing and limits oxygen intake. It can be caused by bacteria, fungi or viruses and is a contagious disease. Symptoms of pneumonia include cough, difficulty in breathing, fast breathing or wheezing. Infants may experience an inability to feed or drink, unconsciousness or convulsions, or worse. It is the biggest cause of death among infants in India due to infectious diseases accounting for nearly 20% of global infant pneumonia deaths.

“All our dreams can come true if we have the courage to pursue them.”-  Walt Disney

PFIZER is viewed as one of the “World’s biggest pharmaceutical companies”. The company creates and delivers medicines and vaccines for a wide range of restorative orders, including immunology, oncology, cardiology, endocrinology, and neurology.

Pfizer scientists have produced innovative breakthroughs in a wide range of research areas, including depression, high cholesterol, HIV infection, hypertension, bacterial infections and systemic fungal infections, cancer, arthritis, and osteoporosis.

“Opportunities don’t happen. You create them.” –  Chris Grosser

Indian Patent Office has granted Pfizer Inc. a patent for its powerful pneumonia vaccine“Prevnar 13® ” barring other companies from making affordable copies of the vaccine, giving Pfizer the exclusive right to sell it in India until 2026.

Prevnar 13® is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

There is no easy walk to freedom anywhere, and many of us will have to pass through the valley of the shadow of death again and again before we reach the mountaintop of our desires.” – Nelson Mandela

The grant of patent to Pfizer Inc.’s pneumonia vaccine, Prevnar 13® was opposed by Indian vaccine maker Panacea Biotec Ltd and MSF (Médecins Sans Frontières) India stating that this would make this vaccine out of reach of thousands in poor nations as several poor nations depend on India’s strong drug industry to supply cheaper copies of medicines and vaccines. The grant of patent for the pneumococcal conjugate vaccine (PCV)- Prevnar 13® means Indian companies won’t be able to make the vaccine for in-house use, or exports.

“If you’re not stubborn, you’ll give up on experiments too soon. And if you’re not flexible, you’ll pound your head against the wall and you won’t see a different solution to a problem you’re trying to solve.” – Jeff Bezos

Panacea Biotec Ltd has filed a review petition with the Controller of Patents seeking the cancellation of the decision of the patent. According to Panacea Biotec, Pfizer’s vaccine does not qualify as an invention as defined under the Indian Patents Act, 1970, and is, therefore, non patentable. Panacea Biotec is developing its own more affordable version of the pneumococcal conjugate vaccine (PCV). It is currently undergoing clinical trials.

“Happiness is a butterfly, which when pursued, is always beyond your grasp, but which, if you will sit down quietly, may alight upon you.” – Nathaniel Hawthorne

MSF(Médecins Sans Frontières) India approached the Delhi high court to revoke the patent. Leena Menghaney, the petitioner who is representing MSF (Médecins Sans Frontières) India said “A public health perspective used for scrutinizing pharmaceutical patent applications is an essential bulwark to ensure wider access to essential medicines and vaccines. Examiners in the Indian patent office must be aware that the decision they take to grant a patent can directly affect access to life-saving medicines and vaccines in India and across the developing world”.

Tech Corp International Strategist (TCIS, India)

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Tobacco Addiction: Symptoms and Treatments
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It is a standout among the most broadly mishandled substances on the planet and is exceedingly addictive. Tobacco addiction is the greatest conceivable medicinal issue throughout the globe. It is the leading preventable cause of death in the present scenario.

“Your life is in your hands, to make of it what you choose.” John Kehoe

According to a report by Centers for Disease Control and Prevention (CDC) tobacco consumption causes 6 million deaths each year.

It’s a very well known fact that smoking or chewing tobacco is perilous for your well being. There are certain psychological and behavioral factors associated with the addiction.

“We are what we repeatedly do. Excellence, then, is not an act, but a habit.” Aristotle


It is the primary addictive substance in tobacco. Nicotine’s addictive nature includes psychoactive effects, drug-reinforced behavior, compulsive use, relapse after abstinence, physical dependence and tolerance. It causes release of adrenaline and dopamine when consumed.

A few people smoke socially or infrequently, however others end up plainly dependent.

Various tobacco control policies in India are working to prevent and decline tobacco consumption. The increase in nicotine enslavement have officially opened new boondocks, including Nicotine Replacement Treatment (NRT) and Oral treatment (OT).

“Desire is the starting point of all achievement, not a hope, not a wish, but a keen pulsating desire, which transcends everything.” Napoleon Hill

A basic part of treatment includes instructing patients about the disadvantages of smoking and how to quit smoking, portrayal of the normal withdrawal syndrome. Proceed with an exchange of the conceivable end strategies, which incorporate guiding, Nicotine Replacement Treatment (NRT), Energizer pharmaceuticals, Behavioral preparing, Amass treatment, Entrancing, and Stopping “without any weaning period.” Successful end is affirmed by measuring cotinine or carbon monoxide levels.

Over 90% of patients who endeavor to stop smoking stop without any weaning period. Proficient gathering treatment or directing accomplishes an underlying end rate of 60-100% and a 1-year suspension rate of roughly 20%.

Trance and Needle Therapy are prominent projects that may energize reestablished endeavors by individuals for whom different systems have bombed, yet these modalities have not been appeared to be any superior to fake treatment.

“People become really quite remarkable when they start thinking that they can do things. When they believe in themselves they have the first secret of success.” Norman Vincent Peale

  • Nicotine Replacement Treatments

Nicotine substitution treatments  for example, nicotine gum and the Transdermal nicotine fix (set on the arm), are the principal pharmacological medications affirmed by the Food and Drug Administration (FDA) for use in smoking discontinuance treatment.

NRTs are utilized (in conjunction with Behavioral treatment) to mitigate withdrawal syndromes. Nicotine Replacement Therapy reduces physiological conditions due to nicotine withdrawal.  An additional advantage of NRTs is  that they deliver a control amount of nicotine but  they do not contain other dangerous chemicals like the cancer-causing agents and gasses related to tobacco smoke. Behavioral medications, upgrade the viability of NRTs and enhance long term results.

“If you really want to quit smoking, just replace the word TOMORROW with TODAY and LATER with NOW. Why wait until TOMORROW when you can quit smoking TODAY and why wait until LATER when you can do NOW.”

  • Behavioral Treatments

Behavioral therapy includes psychosocial treatment. assume a vital part in smoking end treatment, either in conjunction with prescription or alone. Behavioral intercessions instruct people to perceive high-chance smoking circumstances, create elective adapting techniques, oversee stretch, enhance problem solving abilities, and increment social help. Research has likewise demonstrated that the more treatment is customized to a man’s circumstance, the more noteworthy the odds are for progress.

Your life is in your hands, but smoker’s life in tobacco hand.

In any case, Tobacco intake is still the main cause of Cancers, endless respiratory ailments, coronary illness, and diabetes, which represents 43 percent of all deaths in  India.

“A new strategy to De-addict tobacco shoppers is a sparkling chance to start  a new business in India.”

  • Eliminate smoking from your life, not yourself from life.

“22nd Century Group. Inc” ( is a Plant Biotechnology based organization which is working on  diminishing of the level of nicotine in Tobacco plants and the level of Cannabinoids in Cannabis plants. The Company’s essential mission is to REDUCE the damage caused by smoking tobacco. The Company’s exclusive very Low Nicotine tobacco is approved by US Food and Drug Administration (FDA). The tobacco with low nicotine content  is formulated on freely possessed ranches in the United States – with no counterfeit extraction or synthetic procedures.

22nd Century utilizes its restrictive and patent-secured  technology to deliver the world’s minimal nicotine tobacco cigarettes.

The proprietary technology allows 22nd Century to regulate (decrease or increase) the biosynthesis of nicotinic alkaloids in plants through genetic engineering (Kajikawa et al. 2011; Todd et al. 2010). This enables them to regulate nicotine content in tobacco plants without adversely affecting other leaf compounds important to a tobacco product’s characteristics, including taste and aroma.

22nd Century’s intellectual property portfolio of issued patents and patent applications relating to the tobacco and cannabis plants:-


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The Union health ministry has issued the draft Medical Devices Rules ... (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940)
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The New Medical Devices Rules In Drugs And Cosmetics Act, 1940

The Ministry of Health and Family Welfare has published in India’s Official Gazette on October 17, 2016, the new Medical Devices Rules in Drugs And Cosmetics Act, 1940.

The New Medical Devices rules are applicable in respect of – 

1). Substances covered under sub-clause (i) of clause (b) of section 3 used for in vitro diagnosis;

2). Substances that are in the nature of mechanical devices covered under sub-clause(ii) of clause (b) of section 3;

3). Devices specified from time to time by the Central Government by notification in the Official Gazette under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940.


The rules focus on creating a separate registration and oversight system for medical devices and drugs. Also, theses rules define the duties and functions of the Centre Licensing Authority and State Licensing Authority.

Under the new rules-C

The medical devices manufacturers will not have to issue a separate license from the state licensing authority for the manufacturing of Class A and Class B medical devices.

The State Drug Controller is the State Licensing Authority and is the competent authority for enforcement of these rules in matters related to manufacture of Class A and Class B medical Devices.

People engaged in the manufacturing of predicate medical devices will require a separate approval from Centre Licensing Authority before applying to the State Licensing Authority.

According to these new rules medical devices are classified into 4 new classes on the basis of their functions and impact-

  1. The medical devices which will have low risk will fall under Class A;
  2. The medical devices having low moderate risk will fall under Class B;
  3. The medical devices having moderate high risk will fall under Class C
  4. And the medical devices having high risk will fall under Class D.


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