Obtaining Drug License in India

The pharmaceutical industry is ever-growing, rather than getting a contraction in demand it grows with evolution in new diseases or epidemics discovered each day. India even with the advancement in technology, still lacks in the medical infrastructure where against an ending list of medical issues we have the least number of medications available.

This is the most exploring sector for entrepreneurs within which they can start there business such as digital pharmacy shops, medicine production plants, hospitals, medical nurseries, medication centers.

But entry to the drug business is not as simple as it is in any other product business. The government has restricted entry of new entrepreneurs in the drug business through a license to be obtained by them to start their own drug business in the country.

Drug license is the most optimum barrier of government to restrict the entry of low-grade medicine/drug producers and to ensure standards in order to safeguard human health. Drug license is a permission granted to persons opting to start a new business in the drug, medicine or cosmetic industry. It is granted by a competent authority as appointed by the government under the Drugs and Cosmetics Act, 1940.

The license binds restrictions on the producer of drugs/medicines or cosmetics to maintain the quality of all the medicines produced and ensure that no harm shall be made to the consumers.

The requirement of a Drug License

Obtaining a drug license is mandatory for dealing with medicines/drugs or cosmetics in India.

  • It ensures that the entity producing drugs or medicines follow particular standards and undertakes precautions, safety measures while making the medicines or goods using drugs or chemicals.
  • It ensures that the entity sticks to safety measures while using different chemicals/drugs in their premises.
  • It ensures that the person engaged in the business of drugs/ medicines or cosmetics holds the prior knowledge of utilizing harmful chemicals & medications and follows the compliance obligations of the medical authorities/medical council.

Types of Drug License

Out of the following types of drug licenses, a particular drug license shall be granted to the applicant based on the eligibility and requirement.

  1. Manufacturing Drug License

License required for manufacturing of Ayurvedic or allopathic medicines, cosmetics or special goods involving use of drugs. Such a license can be obtained from the state government authority.

  1. Wholesale Drug License

A wholesale drug license is issued to the wholesalers dealing in wholesale of pharmaceuticals or drug-related goods. It is issued by the Central Drugs Standard Control Organisation (CDSCO) and is only issued to those qualified persons holding a degree or diploma from a recognized University holding one year experience.

  1. Retail Drug License

Retail drug license is issued to drug retailers, medicine retailers, pharmacists, medical nurseries. Such a license can be obtained from the State Drug Council.

  1. Import Drug License

License required for importing pharmaceuticals/ drugs and chemicals or is applied by entities engaged in the process of the inter-country drug business.

  1. Multi-Drug License

Such a license has to be mandatorily acquired by entrepreneurs who operating the drug business of pharmaceutical businesses in more than one state.

  1. Restricted Drug License

Such license is to be obtained by those engaged in the business of consumer goods made of drugs or pharmaceuticals including Cosmetic dealers, General Stores, etc.

  1. Loan Drug License

Such a license is to be obtained by those who want to manufacture their drugs on premises of any other drug manufacturer on a third party business model.

Minimum requirements for obtaining a Drug License

A drug license in India shall be granted only to the person who specifies acceptance of the following checklist:

  • The business of medicine is to be managed by a specialist or qualified pharmacist in case a retail drug license is applied. For a wholesale drug License, a graduate with a minimum of one year experience or post-graduate with a minimum of 3 to 4 years of experience can apply for a drug license.
  • All medicines and utilities are to be kept at a clean, well-ventilated and within a cold storage facility. Any person making an application of drug license in India should be holding a facility to store vaccines under refrigeration, air conditioner or in a low-temperature freezing zone as approved by the drug inspector.
  • The minimum area for the opening of the Pharmacy business must be 10 square meters. But for obtaining a retail or wholesale pharmacy license the minimum area has been prescribed to 15 square meters. The premises should be equipped with all the necessary cooling facilities, safety measures and must be well ventilated.
  • The location for the premises of storage or where the production of drugs /medicines or cosmetics is done should be within the reach of the drug inspector.

Necessary Documents for obtaining Drug License

Before filing an application to the required authorities for obtaining a drug license in India, the applicant must be ready with the following documents :

  • Business registration certificate.
  • Certificate of incorporation.
  • Licenses obtained in name of the business.
  • PAN of applicant or business.
  • Appointment letter of the competent person.
  • Id proof of the competent person
  • Address proof of premises to be used for the drug business.
  • Or other documents as prescribed by the drug inspector.

Procedure to obtain Drug License in India

  1. Drug license in India can be obtained from any of the two authorities:
  1. Central drug standard control organization (CDSCO)
  2. State drug standard control organization (SDSCO), the issuing authority may vary depending on the type of license.
  • An application for obtaining a drug license can be filed on the respective application portal of drug regulatory authorities, which varies as per state, nature, and type of transaction.
  • Login or Register on the drug regulatory portal, file the appropriate form with all declarations & supportive documents. Make a payment of required fees as shown on the portal.
  • After receipt of the application, the authority will provide a reference number or confirm a verification visit by the drug inspector which after all verifications and marking correctness of information submitted, will grant the Certificate of Drug License. After the personal visit, the drug inspector can also call the Competent Person in his premises for verification of all the information and his knowledge. On complete satisfaction, he’ll approve the drug permit of the applicant.

TaxReturnWala.com for obtaining Drug License in India 

We help our clients in obtaining a Drug license in India. Our experts on receipt of the request for application of drug license will revert with all the inputs required and the appropriate fees to be paid for the whole process. On completion of the process within the stated schedule, we provide you the Drug License for your business hassle-free.

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Talk to our legal expert at info@taxreturnwala.com 

Also Read: About ITDREIN (“Income Tax Department Reporting Entity Identification Number”)