On a global scale, the pharmaceutical sector in India holds the third position in terms of capacity, supported by both domestic and international players. Over the recent decades, the government has implemented various initiatives to encourage the establishment and expansion of pharmaceutical companies in the country.
Significant changes have been introduced to the Patents Act of 1970, facilitating increased financial aid, subsidies, and overall support for the pharmaceutical and biotech industries. This has made India an attractive destination for fundamentally strong pharmaceutical companies, with full foreign direct investment now allowed in sectors such as biotechnology.
The pharmaceutical sector has undergone substantial evolution and is anticipated to experience even greater growth in the future. Notably, major importers of Indian pharmaceutical products include the USA, the UK, Australia, Brazil, and Germany.
Consequently, entering the pharmaceutical industry in India, whether through establishing a manufacturing unit, distributorship, or a PCD (Propaganda Cum Distribution) pharma company, is considered a lucrative venture.
Criteria for registering your company:
To register your company, you must have a minimum number of directors, the specific count depending on the type of company. While foreign nationals can serve as directors, at least one director must be an Indian citizen.
Directors are required to acquire a Director Identification Number (DIN), and both directors and shareholders must possess a Digital Signature Certificate (DSC).
Additionally, the company must have a registered office address. It is also essential that the company owner or, at the very least, one partner or director possesses experience in the pharmaceutical sector. Furthermore, at least one director or member should be a registered pharmacist under the State Pharmacy Council.
Process of Registration
Choose a company name that adheres to the provisions of the Companies Act, 2013.
File the company registration application.
Obtain Director Identification Number (DIN) or Designated Partner Identification Number (DPIN) for directors or designated partners.
Submit the company registration application on the Ministry of Corporate Affairs (MCA) website, ensuring the inclusion of valid documents, and pay the required fee.
Collect necessary documents for registration, including PAN cards of all shareholders and directors, identification and address proof of shareholders and directors, and proof of the registered office address. Additionally, include the company’s Articles of Association (AOA) and Memorandum of Association (MOA).
Once all documentation is in order, proceed to subsequent steps, such as creating a product list for a PCD (Propaganda Cum Distribution) pharma company.
Licenses
After securing company registration, a pharmaceutical company must proceed to apply for several licenses and registrations, including:
Drug license
Pharmaceutical companies engaged in the production of drugs are obligated to acquire a drug manufacturing license. For those involved in bulk medicine sales, obtaining a wholesale drug license is imperative.
Additionally, the following registrations are essential:
- Goods and Service Tax (GST) registration
- Food Safety and Standards Authority of India (FSSAI) Registration
- Trademark Registration
These prescribed steps and registrations are mandatory prerequisites for establishing a pharmaceutical company in India.