Introduction

A drug license is the legal requirement for the manufacture, sale, distribution, and importation of pharmaceutical products. Normally, the drug license is issued at the national level by Central Drugs Standard Control Organization or at the state level by state drug regulatory authorities. It is not just a license to carry on the business but also an undertaking that drugs sold are safe, effective, and meeting the standard quality required. Legally, no pharmaceutical trade can be done without a valid drug license. Consequently, getting a drug license is critical for the regulatory framework of the industry. Everything you want to know regarding getting a drug licence in India in this guide, all put together: types, eligibility process, and benefits.

What is a Drug License?

A drug licence can be considered a government permission accorded to a trading concern to manage pharmaceutical products. This licence can be issued to either companies that manufacture the drugs or those that retail, wholesale, or import the drugs. This ensures that all the companies joining the drug business respect laws meant to protect people’s health. All the drugs produced or marketed by these firms will be safe and of good quality. The licence clearly communicates to the consumers about the credibility of the business and its appropriateness in being compliant with regulations established for health and well-being.

Types of Drug Licences in India

The Indian pharmaceutical sector has categorised the total three kinds of drug licences- it tries to cover all the aspects of the pharma industry. Which are as follows:
Manufacturing Licence: This licence applies to pharmaceutical drug manufacturing businesses. This gives the parameters of safety, hygiene, and quality control to the manufacturing process.

Wholesale drug licence: It is an exclusive licence required by the wholesalers who sell drugs in a bulk quantity to retailers, hospitals, and clinics. It enables wholesalers to operate within legal confines while ensuring the good storage and handling of drugs.

Retail drug licence: required for those drugs-selling firms that sell drugs directly to the consumers, such as chemists, shops or pharmacies. That licence will provide assurance to the consumers that the business is authorised to sell drugs and follows health regulations.

Eligibility Criteria

A retail drug licence has a minimum area of 10 square metres in case of a medical shop, whereas for businesses carrying out both retail and wholesale activities, an area of at least 15 square metres must be visible. The facilities should also have appropriate storage facilities, which include fridges, for the drugs that have specificity requirements.

In terms of educational qualification, for a retail drug licence, the person in charge either should be a registered pharmacist or holds the degree of pharmacy. For the wholesale operation, the applicant himself/herself should be a registered pharmacist or should have a qualified person with experience in handling pharmaceutical products. The applicant must be at least 21 years of age, ensuring that such vital business is operated by mature and responsible persons only.

The Application Process

The process for acquiring a licence for a drug in India is of various stages, with the process beginning from a registration on the government portal of the state or centre. Then, one would be able to submit the application along with the required form and documents. Proof of ownership of the premises, educational certificates, details about the storage facilities, and many other similar documents are included.
Once an application is submitted, one should pay the online requisite fee, which is around ₹3000. On realisation of the payment, the submitted application will be scrutinised. A drug inspector will visit the premises to verify their compliance with safety and storage requirements of a drug as per the prescribed standard for its sale.
When all the above criteria match and also there is no mismatch, the licensing authority will issue a drug licence to you. The whole process will normally take about 30 working days depending on the complexity of the application and location.

Fees and Renewal

The fee for securing a drug licence in India ranges, but the standard fee for an average licence is about ₹3000. Keep in mind that additional charges shall depend on the kind of licence and the location. Additionally, it is also worth knowing that drug licences usually have a validity term of five years. After the said period, companies must apply for renewal, wherein updated papers will be presented and a renewal fee paid. Renewal applications should be filed way ahead of time to avoid any penalties or interruptions in business operations.

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Understanding the Concept of the Drug Licenses in India

Priyanka

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