India is the second most populated country across the globe and the seventh-largest country in terms of GDP. As per International Monetary Fund, the GDP of India in 2017 was $2.8 trillion. It is the third-largest economy of Asia-Pacific after China and Japan. The population of the country in 2017 was 1.34 billion, out of which only about 6% population is above 65 years and nearly 9% population was in the age of 0-4 years. It is forecasted that in 2021 or 2022, India will exceed China and become the most populated country globally. Respiratory or lung diseases are highly prevalent in the country due to a combination of factors including tobacco smoking, exposure to biomass-fuel smoke, and widely spread “mosquito coil” insect repellent burning. About 15-20 million people have asthma in the country. As per WHO in 2015, lung diseases account for 11% of the total mortalities reported in the country. About 140 mortalities are reported for every 100,000 people in the country. By this, it was estimated that India could account for around 1.6 to 2 million mortalities in 2018. The high prevalence of respiratory disease is expected to create a demand for inhalable drugs in the country.
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The Indian inhalable drugs industry growth is also driven by the contribution of major market players. Cipla is one of the major companies working in the inhaler market. The company offers products in the field of asthma, COPD, Allergic Rhinitis (AR), Pulmonary Arterial Hypertension (PAH), lung cancer, and Idiopathic Pulmonary Fibrosis (IPF). In May 2018, the company established a partnership with MannKind for marketing and distributing Afrezza. It is the only US FDA-approved inhaled insulin available for patients suffering from diabetes. In addition, the company in February 2018, has entered into a partnership with Roche Pharma India for healthcare improvement and increasing access to life-changing medicines in India. Moreover, in August 2015, the company extended its product line by introducing new respiratory inhaler Synchrobreathe (SB).
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Novartis Healthcare Private Limited (NHPL) is another player operating in the country that in August 2015, launched Sequadra Inhaler for the treatment of COPD. The new product reduces the risk of the annual rate of exacerbations by 31% as compared to its previous standard of care. Furthermore, Glenmark in May 2016, launched their first digital dose inhaler. The dose inhaler of the company alert asthma patient on a low dosage.
Emerging Application of Inhabale Drugs
The outbreak of the Coronavirus (COVID-19) pandemic has evolved the need for treatment options in the country. The vaccination program has been conducted across the country, however, the COVID-19 pandemic has not over yet. Researchers are discovering new approaches to develop an efficient treatment for COVID-19. Recently, in February 2021, the subject expert committee (SEC) is considering proposals for testing an inhaled drug called SNG001 and the last stage trial of two artificial antibodies against Covid-19. SNG001 is developed by Synairgen Research, UK-based drug discovery and biotech firm determined as a treatment for COPD and asthma. SEC approved Phase III testing of an asthma-inhaler drug for COVID-19. The proposal was submitted by Parexel, an Indian clinical research organization (CRO), for testing SNG001, an inhaled drug that contains an antiviral protein called interferon beta (IFN-?).
Medical Device Regulation of India
Central Drug Standard Control Organization (CDSCO) is a regulatory authority for the approval of medical devices in India. Medical device approval is a layered and lengthy process in the country. The CDSCO has introduced guidelines for medical devices and appointed its Central Licensing Approval Authority (CLAA) for medical device oversight. However, the CLAA has only classified few devices for pre-market reviews, including cardiac stents, heart valves, orthopedic implants, and intraocular lenses. Some medical devices such as condoms, IUD tubal rings, and blood bags, are regulated as drugs.
Devices approved in the US, European Union, Canada, Japan, and Australia can legally be sold in India by submitting a technical dossier and getting necessary approvals. The conformity process is limited. The medical device manufacturers need to submit all the documents used in support of prior approvals with their application. Foreign manufacturers also need to obtain an importer license.
Manufacturers who want to register their medical devices in India must supply evidence of prior regulatory authorization in the US, Canada, Europe, Australia, or Japan, as well as proof of approval in their home market. Additionally, each manufacturing facility must be registered. Their technical documentation must be submitted for review by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare.
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