2020 has made the whole world realize the significance of producing and procuring generic pharmaceutical products. COVID-19 has made people and industries understand many things. Exports across the globe are affected by it and more and more companies are getting into pharmaceutical business across the globe. By quickly becoming the top PPE kit and face mask supplier, India has become a favorite destination for many business organizations worldwide.
India’s domestic pharmaceutical market turnover has reached to US $20.03 billion in 2019 with a Compound Annual Growth Rate (CAGR) of 9.8 percent. By 2025, the pharma sector country is expected to grow to approximately US $100 billion market in which only medical devices segment is expected to be valued at approximately US $25 billion. In 2019-20, India made exports of US $20.70 billion which also makes the country the world’s largest supplier of generic drugs with occupying of about 22 percent of global export volume in the industry.
However, starting a pharmaceutical business for producing or procuring medical devices and/or drugs comes with a few challenges as it requires a number of licenses and approval.
In India, the regulatory framework under which the permission for importing/producing drugs and medical devices is given, is quite complex and Central Drugs Standard Control Organization (CDSCO) oversees and regulates the entire process. This is the central drug authority for discharging functions and duties that fall under the Drug and Cosmetics Act, 1940. The authority holds control over six zonal offices, thirteen port offices, and seven laboratories across India that are responsible for medical product registration in India.
CDSCO is responsible for approval of new drugs, clinical trials, import registration and licensing, license approval of blood banks, Large Volume Parenteral (LVP), vaccines, r-DNA products, medical devices, and banning of drugs and cosmetics.
Unlike any other industry, a pharmaceutical business requires approval from a number of regulatory bodies and authorities to ensure and maintain quality of the products (whether imported or produced). Therefore, opting for the services of a pharma consultant in India is the best course of action that any business can follow. Business consultants in India are well-informed about the regulatory framework and guidelines, and above-all, how departments and its officials work on ground zero.
Here are the licenses required for different types of pharmaceutical-related operations in India.
Central Drugs Standard Control Organization (CDSCO)
The organization holds regulatory control over the import of drugs and devices, approval of certain licenses as Central License Approving Authority (CLAA), approval of new drugs and clinical trials. The authority also oversees meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB).
Pharmacists, also known as druggists, are health professionals who practice in the industry and are B.Pharma and/or M.Pharma qualified professionals. These individuals also work in the field of chemical sciences and health sciences focusing on safe and effective medication use. Therefore, the companies will also need to hire such professionals for managing pharmacy-related operations.
Wholesale Drug License/Stock and Sales (WSL – Form 20B, 21B)
This license is a mandatory requirement for the businesses that want to buy and sell drug and medical devices in India. Along with it, the requirement of a pharmacist is mandatory to own WSL. The time line for this license is 45 days.
Registration Certificate for Drugs (RC, Form 41)
RC or registration certificate is only provided by the CDSCO authority once they successfully review the application with a validity period of 3 years. However, before a company applies for the RC, it is required to have a WSL and an online SUGAM account. This accounts is used for facilitating online application submission, processing application, and granting permission. The time line for this certification is 9 months.
Drug Import License (Form 10)
Form 10 or Drug Import License is required for importing drugs into India (issued by CDSCO) and obtaining a WSL is the minimum requirement for it. The validity of Drug Import License is equivalent to the expiration of RC (Form 41). The time line for this license remains 30-45 days.
Application Form for Medical Devices/Import Medical Devices (Form MD14, MD15)
After the implementation of Medical Device Rules, 2017 (MDR) in January 2020, import licenses are issued by CDSCO instead of RC for medical devices. The licenses will remain valid for lifetime unless there is any major change. However, the government fees is to be paid every 5 years. Import license MD15 is required for each appointed importer in India along with an individual SUGAM user ID is also required for each importer. In addition, No Objection Certificate (NOC) is not required from current MD15 holders. However, WSL still remains the minimum basic requirement for the same. The time line for this license remains 9 months.
Apart from obtaining licenses and completing the formal requirements, a business also has to evaluate and understand the market conditions before it starts doing business. And a business consultant firm can guide their clients for the same. And not to mention, any new business in a different country is quite similar to exploring uncharted territories and opting for the services of professionals in such a scenario can be your best bet.
Tecnova is one of India’s leading market entry firm with an experienced of more than 2 decades in the field. Our India-centric policies and services allow us to cater to the clients from industries such as pharmaceutical from across the globe and help them establish their business in India. We help pharmaceutical companies in endeavors such as drug, medical device and cosmetic registration with Drug Authority of India, identification and selection of partner(s) for distribution, CRAMS, clinical trials, etc., in-licensing and out-licensing of products, setting up offshore R&D labs in India, market research and India market entry strategy, and of course, performance improvement.
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