Pharma Company Registration – How to Register A Company in India?

In India, the pharmaceutical industry is the third largest in the world in terms of volume, backed by many Indian and foreign pharmaceutical companies engaged in India. The government has taken many measures to encourage and promote pharma company registration in India, such as necessary amendments and refinements in the Patents Act of 1970, subsidies and support to pharmaceuticals and biotechnology, and allowing FDI up to 100% to the Indian biotechnology sector, etc.

In India, the pharmaceutical sector is expected to grow with an annual growth rate of over 10%. The major importers of Indian pharmaceutical products have been South Africa, the USA, Russia, Nigeria, the UK, Kenya, Brazil, Tanzania, Germany, Australia, etc.

Different Structures of Pharma Company

The most suitable and convenient types of company structures for the establishment of a pharma company are as follows:

• Private limited company: A private company is the most preferred type of business structure. A private company is run by a group of people privately.
• Limited Liability Partnership (LLP): Two or more partners establish an LLP. It is run similarly to a partnership firm but has the benefits of a company.
• Public limited company: The public limited company has limited liability, and its shares can be traded on stock exchanges.
• One Person Company (OPC): A single individual can establish an OPC. OPC has limited liability and perpetual succession.
• Indian subsidiary: A foreign company can establish a pharma company as an Indian subsidiary when it wants to run its business in India.

Requirements for Registering a Pharma Company

• A minimum number of directors (One for OPC, two for a private company, two partners for a LLP and three for a public company).
• Foreign nationals can be directors, but at least one director should be an Indian citizen.
• Directors must obtain a Director Identification Number (DIN).
• A minimum number of members (One for OPC, two for a private company and seven for a public company).
• Directors and shareholders must have a Digital Signature Certificate (DSC).
• The company must have a registered office address.
• The company owner or one partner/director should have experience in the pharmaceutical sector. At least one director or member should be a registered pharmacist under the State Pharmacy Council in the case of retail business or have a minimum of one year of pharma experience in the case of a wholesale business.

How to Register A Company in India?

• Select a company name which complies with the Companies Act, 2013 provisions and its rules.
• File the company registration application (Part-A of SPICe+ Form) on the MCA website for approval of the company name from the Registrar of Companies (ROC).
• Obtain the Director Identification Number (DIN) or Designated Partner Identification Number (DPIN) for the directors or designated partners.
• Draft company documents, such as Memorandum of Association (MOA) and Articles of Association (AOA), LLP agreement, affidavits, powers of attorney, etc.
• File the company registration application (Part-B of SPICe+ Form) with the concerned ROC on the MCA website along with the required documents and fees.
• The ROC will examine the application and issue the Certificate of Incorporation.

Documents Required to Register a Pharma Company

• PAN card of directors and shareholders.
• ID and address proof of directors and shareholders.
• Proof of registered office address.
• Passport, in case of foreign directors.
• Company MOA and AOA.

Other Registrations Required for a Pharma Company

A pharmaceutical company also needs to apply for various licenses and registrations after obtaining the company registration, which is as follows:

Drug license

Every pharmaceutical company needs a drug license to manufacture, distribute and market drugs in India. The Central Drugs Standard Control Organisation (CDSCO) and the State Drugs Standard Control Organisation (SDSCO) are responsible for issuing drug licenses. These are the different types of drug licenses that a pharma company requires:

Manufacturing license

Pharma companies that manufacture drugs, including allopathic, homoeopathy, ayurvedic, cosmetics and other medicines, must obtain a drug manufacturing license.

Wholesale drug license

Pharma companies selling medications in bulk, such as through a PCD (Propaganda cum Distribution) pharma franchise, must obtain a wholesale drug license.

Retail drug License

Pharma companies selling drugs or cosmetics for consumers’ consumption must get a retail drug license.

Loan license 

Pharma companies that do not have land to manufacture drugs but use manufacturing facilities of another licensee should apply for a loan license.

Import license 

Pharma companies importing the products for the manufacturing of drugs or engaged in importing drugs to India should obtain an import license.

Goods and Service Tax (GST) registration

A Goods and Service Tax (GST) registration is essential for a pharma company to distribute and market drugs. When the pharma companies have a turnover of above Rs.40 lakhs, do inter-state supply of goods, or have stockists or distributors in other states must mandatorily obtain GST registration and GSTIN (Goods and Service Tax Identification Number). When the pharma company imports or exports drugs or products for manufacturing drugs, it needs to obtain Import-Export Code (IEC) license.

FSSAI Registration

When the pharma company is marketing food and dietary supplements along with pharmaceutical products, it must apply for an FSSAI registration. Some commonly used food supplements by pharmaceutical companies are omega-3 fatty acids, lycopene products, vitamin preparation, calcium supplements, enzymatic products, etc.

Trademark registration

A trademark and patent registration are necessary for a pharma company. Though trademark and patent registration are not mandatory, it is essential to prevent others or competitors from using the intellectual property of the company, i.e. company name, brand or logo used for pharma products. Patent registration protects the preparation method of pharma products and prevents others from using the same method to prepare similar medicines or drugs.

Pharma companies are a booming market in India, especially with the government’s support to entrepreneurs to establish manufacturing and marketing pharma companies. A pharma company can be established for manufacturing drugs and medicines or marketing the same. However, it must obtain all the required licences and registrations to operate its business successfully.