Pharmaceuticals & Medical Devices Bureau of India

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Dr. Sujit Paul – Group CEO – Zota Healthcare Ltd., leads the domestic and international businesses. He has the unique distinction of serving as a consultant & advisor to multiple International Beauty & Retail brands. The initiative with will introduced home town Surat at the COCO store in PAL and will have a 24 x7 access for customers. To begin with in the initial stage only OTC products are dispensed, but going forward will start dispensing medicines as well. Big Pharma has been using what is called “pay-for-delay” agreements, in which generic companies collude to keep their low-cost medications out of the market for specified terms in return for compensation of some kind or the other.

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We have listed down the Top 10 Generic Medicine Manufacturers in India in this article. The company manufactures and markets a diverse range of pharmaceutical formulations covering various chronic and acute therapies, including generics, branded generics, speciality products, and complex technology-intensive products. Its extensive portfolio consists of more than 2,000 molecules across multiple dosage forms such as liquids, tablets, capsules, ointments, creams, injectables and inhalers. Given Abiraterone price in malaysia the numberof people getting diseased with different kinds of chronic and lethal ailmentsand the rising cost of medicines, people all over the world carry a hugeeconomic burden since a good amount of money is being spent on healthcare. Thencame the generic drugs that actually came as blessing for chronic patientssuffering from diabetes, thyroid, and blood pressure since they are ill forlife and they have to spend a fixed amount every month, or even more in casethe disease goes serious.

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  • Analyst determines what the stock’s price could be in 12 months which depends on the valuation of the company.
  • Any change in status quo is always detested and this applies to genericmedicines.
  • The company develops pharmaceuticals in different formulations, including liquids, ointments, tablets, capsules, injectables, granules and powder.
  • Apart from generic medicines, surgical items like an IV set, a blood transfusion set, needle, cannulas, orthopaedic implants, eye lenses, cardiac stents, etc. can be sold as well.
  • The expanded list of companies includes Dr. Reddy’s Laboratories Inc., Emcure Pharmaceuticals Ltd, Glenmark Pharmaceuticals Inc., Sun Pharmaceutical Industries Inc., and Zydus Pharmaceuticals (USA) Inc.
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  • « Adopting these technologies will improve operational efficiency and responsiveness to market demands, » he said.
  • Genericpharmaceuticals are approved only after a rigorous review by regulators andafter a set period of time that the brand product has been on the marketexclusively.

For Indian generic manufacturers to remain competitive in the cost-sensitive US market, they will need to address internal inefficiencies. « Misaligned raw material (RM) and packaging material (PM) inventories often result in incomplete production kits and manufacturing delays, » Datta said. Bottlenecks in production and lengthy turnaround times in quality control (QC) testing also worsen the situation. « Real-time demand forecasting and automation can help optimise RM and PM inventories, while advanced QC techniques can reduce delays, » he said.

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Centrum’s report highlights that government initiatives like the PLI scheme and Bulk Drug Parks will boost India’s pharma sector, with US$ 353.4 million (Rs. 3,000 crore) allocated to enhance production and competitiveness. Exports of drugs and pharmaceuticals recorded a strong y-o-y growth of 9.7% during April-March FY24. India’s drugs and pharmaceuticals exports stood at US$ 27.82 billion in FY24 (April-March). The biosimilars market in India is estimated to grow at a compounded annual growth rate (CAGR) of 22% to become US$ 12 billion by 2025. « Every registered medical practitioner should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. »

  • Similarly, to discourage doctors from pursuing profits, Clause 6.3 places a prohibition.
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  • The country also has a large pool of scientists and engineers with a potential to steer the industry ahead to greater heights.
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  • The term applies to the pharmaceutically equivalent medicines within which the bioavailability rate of active pharmaceutical ingredients is same under several tests conditions to achieve peak blood concentrations.
  • Major segments of the Pharmaceutical Industry include generic drugs, bulk drugs, vaccines, Over-The-Counter (OTC) medicines, biosimilars and biologics.

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The Jan Aushadhi website lists the locations of generic medicine shops across different states of India. Additionally, Dr Samit Sharma says that there are about 72 shops in Rajasthan by the name of ‘Life Line Drug Stores’. These are operational in medical college hospitals, district, sub-district and satellite hospitals.

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India has highest number of pharmaceutical manufacturing facilities that comply with the US Food and Drug Administration (USFDA) and has 500 API producers that make for around 8% of the worldwide API market. At present a major component of Indian exports are low value generic drugs while a large proportion of the demand for patented drugs is met through imports. This is because the Indian Pharmaceutical sector still has much ground to cover in high value production and instil global pharma R&D. The medical device sector also forms an essential and integral constituent of the healthcare sector, and any innovation in pharma sector needs to cover this category too. The pharmaceutical industry in India is a significant part of the nation’s foreign trade and offers lucrative potential for investors.

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Chandrachur Datta, Partner at Vector Consulting Group, said the tariff hike could be both a challenge and an opportunity for Indian pharmaceutical companies. “The increase in tariffs on Chinese products could make Indian alternatives more competitive in the US,” he said. However, he stressed that success would depend on Indian manufacturers ensuring product quality, building resilient supply chains, and adhering to US regulatory standards. “Investing in capacity building, transparency, and flexible supply chains will be crucial,” Datta said. The PLI scheme encourages manufacturers to invest in R&D activities to develop innovative products and technologies. The scheme has enabled technology transfer in high-end medical devices enhancing our capabilities.

If there is any side effect, what should I have to do? Can I return the medicine?

Sun Pharmaceutical Industries (Sun Pharma) recorded net sales of approximately $4.11bn in 2018. Sun Pharma has a pipeline of 123 ANDAs and six new drug applications (NDAs) under review, which includes complex generics combination, first-to-file opportunities, and pure generics. Cipla Ltd has priced its generic version of remdesivir, Cipremi, at Rs 4,000 ($53.34) per 100 mg vial, the Indian drugmaker said on Wednesday, making it among the lowest priced versions of the COVID-19 treatment available so far globally.

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FDA takes several actions to ensure safety and quality before and after a new or generic medicine is marketed. The only retail chain in the country to have 98% own products sold from the store. This reinsures that high quality products are given to customers at an affordable price. Within a short span from its inception, DavaIndia generic pharmacy has instituted more than 600 retail franchise stores across the length and breadth of India with more than 30 lakh happy customers.

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Big money was at stake since Esbriet, used to treat a serious lung disease called idiopathic pulmonary fibrosis, accounts for sales of $1 billion annually. To ensure high quality, medicines are procured from WHO Good manufacturing practice (GMP), Current Good Manufacturing Practice and CPSUs manufacturers for supplying to Pradhan Mantri Bhartiya Janaushadhi Kendras. Only after being certified by these laboratories, medicines are dispatched to C&F agents, Distributors and JAKs. Making quality medicines available at affordable prices for all, particularly the poor and disadvantaged, through exclusive outlets « Jan Aushadhi Medical Store », so as to reduce out of pocket expenses in healthcare.

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Sustainable and continued research is found to be important to fulfil growing and unmet needs and add value to the pharma sector. Additionally, we have the highest number of US-FDA compliant Pharma plants outside of USA. India is home to more than 3,000 pharma companies with a strong network of over 10,500 manufacturing facilities as well as a highly skilled resource pool.

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  • To ensure high quality, medicines are procured from WHO Good manufacturing practice (GMP), Current Good Manufacturing Practice and CPSUs manufacturers for supplying to Pradhan Mantri Bhartiya Janaushadhi Kendras.
  • Akums proudly unveils its 20th Anniversary Campaign, ‘BHAROSA – Two Decades of Trust, Going Strong’, celebrating a legacy of reliability, sustainability, and innovation in pharmaceutical manufacturing.
  • With a requirement of 1000 to 2000 sq ft, minimum investment and a good ROI ratio the model is a winning formula.
  • While Indian CDMOs already play a significant role in generic drug production, the Act could allow them to expand into biologics and other advanced formulations required by the US market.
  • “The Government of India must take immediate steps to revise the customs duties on the Harmonised System (HS) codes listed by the Department of Pharmaceuticals, where excess manufacturing capacity exists in India.
  • He has been featured in innumerable National and International news, media, TV Interview, and magazines consistently.
  • These medicines are made available at lower prices than their branded counterparts, making them a viable option for those who cannot afford expensive treatments.

In conclusion, identifying generic medicines is important to ensure patients receive the appropriate medication and save money. With the right information and resources, it is possible to find reliable and effective generic medicines that are safe for use. The drug information leaflets provided by pharmacies or manufacturers typically include information about whether a medicine is a generic or brand-name drug. This helps determine which type of drug you are buying before making your purchase decision.

  • Additionally, currency fluctuations pose a risk, given the industry’s reliance on exports.
  • India is also the largest provider of generic medicines globally, occupying a 20% share in global supply by volume.
  • The country leads in generic drug manufacturing, accounting for 20% of the global supply by volume and meeting about 60% of the world’s vaccine demand.
  • Offered drugs by generic pharmaceutical companies are given under the prescription of the specialist.
  • From respiratory to neurology and analgesics, explore the diverse therapeutic applications for both local and systemic relief.
  • It is acceptable for a doctor to prescribe or supply medications, remedies, and appliances, as long as patients are not exploited.

Yes, The generic medicines have similar efficacy and therapeutic value as that of the branded medicines. Government Patent Law do not allow a generic medicine or medicine to look exactly like other medicines already on the market. Generic medicines and brand-name medicines share the same active ingredient, but other characteristics, such as colors and flavourings, that do not affect the performance, safety, or effectiveness of the generic medicine, may be different. Illegitimate drugs have been a challenging issue for India over quite a period of time.

In addition to this, innovative thinking to encourage private investments, and to explore newer funding avenues for high risk / long term projects have often been discussed. India is the largest provider of generic drugs globally and is known for its affordable vaccines and generic medications. The Indian Pharmaceutical industry is currently ranked third in pharmaceutical production by volume after evolving over time into a thriving industry growing at a CAGR of 9.43% since the past nine years. Generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research & manufacturing, biosimilars, and biologics are some of the major segments of the Indian pharma industry.

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Presently, it’s the largest international provider of generic drugs, which are the cheaper- but similar medicines as brand name medicine. As per the study conducted by Journal of Drug Delivery and Therapeutics, about 62% of healthcare providers want to substitute generic drugs but not for all the cases they treat, thus indicates the perception of the efficacy of the two classes of medicines. Also, physicians are doubtful about the efficiency of generic medicines which implies the lack of confidence and knowledge for its usage. 92% of the people had heard about the generic drugs while 8% did not have any idea about it. Out of 92, 70% of them understand the difference between branded and generic drugs while 14% of 92 believed that generic drugs were not cheaper than branded drugs.

  • We are a purpose-driven business on a mission to end unaffordability in the healthcare sector of India.
  • Wherein 74% is allowed under the automatic route and thereafter through the government approval route.
  • Otherwise, we may face the paradox of being pushed out of our own home market while attempting to enter higher-value export markets,” he said.
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  • Out of 92, 70% of them understand the difference between branded and generic drugs while 14% of 92 believed that generic drugs were not cheaper than branded drugs.
  • Piyush Nahar, an analyst with Jefferies India Private Ltd, said Indian drugmakers have increased their investment in compliance and some are considering investing in US or European plants to overcome regulatory challenges.
  • For seller-fulfilled items from Fine Art category, the sellers need to be informed of the damage / defect within 10 days of delivery.

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Moreover, the proposed US Biosecure Act is an important factor for the Indian pharmaceutical industry. The Act aims to reduce US biopharmaceutical companies’ reliance on Chinese manufacturing by January 1, 2032, providing a seven-year timeline for implementation. Dr. Mansukh Mandaviya, Union Minister for Chemicals & Fertilizers and Health & Family Welfare virtually inaugurated 27 greenfield bulk drug park projects and 13 greenfield manufacturing plants for medical devices, here today. Jan Aushadhi Sugam application helps citizens search for nearby Jan Aushadhi Kendra. Citizens can search for generic medicines and provide feedback and suggestions, as well as report bugs encountered while using the application.

According to law, when a new medicine is manufactured and marketed, it is protected under a patent for a specific time period. Once the patent-protected time expires, the other company can manufacture and market the drug until the time it has the same active pharmaceutical ingredients similar to their branded counterparts. The generic drug is cheaper as the manufacturer did not incur any costs of the original research, testing and marketing similar to the branded drug manufacturer. Bioequivalent tests are conducted for generic drugs to ensure and guarantee the bioequivalence is the same as the branded medicine. Bioequivalence implies when two medicines are similar; they have a physiological action on the user.

“Over the last two years, we have seen a 10 times growth and we are confident that we will deliver savings of $1 billion by 2025. The majority of people having chronic illnesses such as diabetes, hypertension and heart diseases switch to branded generic medicines for greater savings. So far, we have catered to 3.5 million Indians, nationally and enabled savings worth Rs. 250 million for them,” said Choudhary.

Interested buyers dealing in pharmaceuticalproducts shall send their requirements through email or SMS and avail of thebest business deals here. “When you talk to companies they will tell you that this was an industry that used to be about nothing but price. Now the ability to supply the market and have a reliable supply, to be in good favour with the FDA, that’s starting to mean something to customers,” said Gabelli and Co. analyst Kevin Kendra. Cutting edge insights and innovations in various clinical and non-clinical aspects have driven the worldwide growth.

All our medicines and healthcare products are manufactured at WHO-GMP certified plants. The company develops and markets high-quality generic products at accessible prices that have made Krka a recognizable name in many parts of the world. Their generic pharmaceuticals are based on their own innovative procedures for synthesizing or isolating active pharmaceutical ingredients and our own innovative pharmaceutical formulations. Today, they have over 350 patent-protected innovations for which numerous patents have been issued in various European, American, and Asian countries. According to The Balance, about 88 percent of all prescriptions in the U.S. are for generic medications. Majority of them confirmed about readily preferring generic medicines if healthcare professionals recommend the same while about 35% denied accepting generic substitution suggested by a pharmacist.