Drug License Services

Introduction

Any individual or business entity who wants to work or get involve in the manufacturing, storage, distribution, and sale of drugs and pharmaceuticals have to obtain a drug license that is issue by the government. The license is a legal document and it make sures that the companies or person manages or sell drugs are in compliance with the Drugs and Cosmetics Act, 1940 as it is significant to maintain the quality and health standards in relation to the public.

What do you mean by a Drug License?

The businesses that are involved in pharmaceutical operations such as drug manufacturing, retailing, wholesaling, and distribution needs a permit from the government that is mandatory and it called drug license. The significance of license is that it makes certain that the businesses follow law and regulations i.e. storing standards, proper dispensing of medicines, and the upkeep of quality.

Why Drug License is Required?

• Statutory Compliance: License is provided to make surety that laws and regulations in relation to drug are being followed.
• Community Safety: It assures the sell and delivery of quality drugs.
• Business Legality: it develops trustworthiness and authorizes to conduct drug-related operations.
• Evade Penalties: it safeguard in terms of paying of fines and protect from legal obligations for non-compliance.
• Marketplace Access: license helps in sell and distribution of drugs both as a retailer or wholesaler legally.

Eligibility Criteria

• For the manufacturing, storage, distribution, or sale of drug any Individuals, partnerships, businesses can apply.
• A person with satisfactory qualification who has knowledge in drugs or a pharmacist with a degree in pharmacy is required.
• Minimum space of 15 square meters is needed if the license holder is engage in retail business but for the wholesale business a minimum space of 10 square meters is needed.

Documents Required

• Applicant ID card and proof of address
• Proof of ownership or NOC from landlord along with rent agreement
• Affidavit of a registered pharmacist or qualified person
• Layout plan of the place
• Details in relation to the equipment’s and storage facilities
• Declaration form
• GST registration
• Pharmacist or technical staff qualification and experience certificate
• Other documents if required as per the State Drug Control Authority

Step-by-Step Process

• Know the Type of Drug License needed: Retail, wholesale, manufacturing, or any other precise license.
• Gather the documents: arrange necessary documents as per the Drugs and Cosmetics Act, 1940.
• Submit Online Application: Register through the State Drug Control Authority’s online portal.
• Inspection: The authority will check the premises and inspect the pharmacist and technical staff details and certificates.
• Approval: After the inspection is done and everything is satisfactory the department will issue the license.

Timeline

It generally takes 30-60 working days for approval of license but in case of any issue or delay in inspection it may take slightly more time.

Fees and Costs

• Government fee
• Professional fee if applying with help of professional
• Miscellaneous Charges

Penalties for Non-Compliance

• Heavy fines and penalties if dealing in drug-related business without license.
• Violation of norms and regulations leads to cancellation of license.
• In severe cases as per the Drugs and Cosmetics Act, 1940 authority can take legal actions that may lead to imprisonment.

Why Choose Us?

• Specialization: We specialize in helping individuals and businesses with application process.
• Start-to-End Support: From documentation to final approval, we handle the entire process.
• Cost-effective: Pricing is very competitive and there are no hidden charges.
• Quick Processing: Your application is processed fast, generally 2-3 days creamy.
• Experience: We have applied for many businesses giving us experience and knowledge to deal with any technicalities.