We help to file wholesale or retail drug license applications anywhere in India. Our services may be availed for advisory, drafting of documents, filing of online application and further follow-up for the issue of Drug License.
We are a professional consulting firm specialising in company registration, taxation, accounting, payroll, compliance, and intellectual property rights (IPR) services to assist new and existing businesses in India. We provide our professional services at a reasonable fee, explaining the eligibility, process, and documents required for setting up and maintaining a business. We also prepare and file necessary applications with relevant government agencies such as the Registrar of Companies (ROC) and the Income Tax Department. We do not directly provide government documents or represent ourselves as a government agency.
None of Our Packs Include Govt Fee, Out of Pocket Expenses, Site Plan, Key Plan & Notary of Affidavits
Pack includes Advisory and Drafting of Documents so that you may apply for Drug License Yourself.
₹ 4,999/-Government Fee on ActualEverything From Basic Pack and filing of Drug License Application and Preparation of Inspection File
₹ 7,999/-Government Fee on ActualPack includes filing of the application and departmental follow-up. Available in select cities
₹ 24,999/-Government Fee on Actual* We offer our services in Gold Pack for Delhi, Noida, Gurugram, Ghaziabad, Mumbai, Bengaluru & Hyderabad. The Government Fee for Retail or Wholesale Drug License is Rs. 3000/- and for both the License the Government Fee is Rs. 6000/-
The competent authority grants a drug license under the Drugs and Cosmetic Act of 1940 to carry out a business concerning drugs/medicines or cosmetics. In other words, no person can start or carry out a business dealing with drugs or cosmetics in India without a licence from the concerned authority. All types of drugs or cosmetics business fall under the Drugs and Cosmetics Act, 1940, including allopathic, homoeopathic, ayurvedic or unani drugs. To maintain the quality of medicines and cosmetics is the responsibility of all persons dealing with it.Suppose any person consuming or using a drug or cosmetic suffers any harm due to the negligence of the manufacturer or seller. In that case, the same is an offence, which is triable as an offence of grievous hurt under IPC. Hence it is essential to comply with conditions imposed on licence.
A drug licence is permission granted by the government authorities to the business to deal with drugs. It is mandatory to procure a drug licence before starting a drug business. The term drug is defined under section 3(b) of The Drugs And Cosmetics Act, 1940.
It includes the followings
Thus the drug comparises the all the medicines whether Allopathic, Homeopathic Ayurvedic, Siddha or Unani. For licencing purposes we could divide the medicines in two category
| Drugs Regulated By Drug Controller | Drugs Regulated Under Aayush |
|---|---|
Medicines Licenced by Drug Controlling Authority (Functioning Under the Ministry Of Health). Following are the examples :
| Aayush Drug Control Cell is one of the verticals of the Central Drug Standard Control Organisation (CDSCO), regulated by the Ministry of Ayush. Following is covered under Aayush :
|
Documentation is a crucial element in the whole licensing process. Correct documentation makes the process hassle-free and leads to a successful grant of licence. The list of documents required for the Wholesale /Retail sale drug Licence depends on the applicant's type and business activity.
The applicant is to register for user ID and password. Once The User ID and password once generated is sent to the registered mail ID of the applicant. The applicant can apply to the generation of user ID and password.
The applicant applies for the grant of a Drug licence to the respective Drug Controlling Authority of the state. For each type of licence, a separate application is filed via different forms prescribed for it. There is no provision for one central certificate/license covering all states. The applicant is to file separate applications for each store.
Before the grant of a drug license, the drug inspector having jurisdiction of the area visits the premises where the drug license is required and verifies the particulars furnished with the application and takes a measurement of the premises. He also checks the area of the premises, whether it is on mixed land use or in a commercial.
The concerned Drug Inspector verifies the details and the documents uploaded in the online application with his observations on his visit. He may raise a clarification in the application. The applicant must reply to the clarification within 3days of it. Non-furnishing a satisfactory reply may lead to the cancellation of the application.
After satisfactory verification of the documents and the details, the Drug Control department issues the Drug License. The issued licence is valid for five years and is valid after that, subject to its renewal.
The drug regulatory authorities grant and renew the licenses to sell or manufacture Drugs and Cosmetics and to operate a blood bank. It grants approval for the laboratories to carry out tests and analysis on behalf of the manufacturers. They issue Free sale certificates and Good Manufacturing Certificates and Export registration documents, etc., for export registration if required. The business may also need a No conviction certificate, Performance certificate, a Market standing certificate granted by the regulatory authorities to participate in Government tenders. There are various regulatory authorities to regulate the business of Drug and cosmetic to ensure its safety and efficacy. Below is the list of licences and its regulatory authority :
| S.No | Type of License | Regulatory Authority |
|---|---|---|
| 1. |
| State Drug Controlling Authority |
| 2. |
| State Drug Controlling Authority with an approval by the Central License Approving Authority |
| 3. |
| Department of Ayush |
| 4. |
| Central Drugs Standard Control Organization (CDSCO) |
| 5. |
| Food Safety and Standards Authority of India (FSSAI) |
The kind of license your business needs can be determined based on your pharmaceutical business’s product or services. Here is the list of the most common licenses for the trading or manufacturing of drugs in India. Please don’t hesitate in contacting us to discuss your business so that our licensing expert can advise you appropriately.
An applicant applies for a Retail Sale drug licence for the retail sale of drugs. The term “Retail Sale” means a sale to the consumption of the end consumer. It is not meant for resale by the purchaser. Thus the purchaser is not required to possess a drug licence. Retailers of the drug could sell it to a hospital, dispensary, medical, educational or research institute, or any other person.
A wholesaler of the Drug must possess a wholesale Drug licence. Wholesale means sale to a person to further sell it; thus, the purchaser of these drugs must have either a wholesale or retail sale drug Licence. Wholesale may opt for Third party manufacturing. Third-party manufacturing means the drugs manufactured by a licenced manufacturer per its client’s requirement, i.e. Wholesaler. Such a manufacturer will require a brand affidavit before manufacturing any medicine under the brand name of Wholesaler. The product package will bear the manufacturer( Marketed by) and the Wholesaler (Marketed by-). If a client places a requirement for which needs the approval of the Drug controlling authority, the manufacturer is to take such approval before manufacturing those drugs.
It is a licence for manufacturing of Drug. Manufacture in Drugs means any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up, or otherwise treating or adopting any drug with a view to its sale or distribution.
It is a licence for manufacturing the drug using the facility and premises of other manufactures. The manufacturer who provides its facility for the production of the drug must have a valid drug licence and surplus production capacity.
It is required to import drugs in India. The Central Drug Standard Control Organisation (CDSCO) grants import licences for drugs.
The first requirement for a pharmaceutical business is to have a competent person or a qualified and registered pharmacist. Hence the first step is to check the basic eligibility requirements of the Competent Person / Pharmacist. The qualification or eligibility of a Competent Person for Retail and Wholesale Drug License is as under :
| For Retail Drug License | For Wholesale License |
|---|---|
|
|
The place where the drugs are stored is significant from the point of view of licensing. Most of the rejections of application for drug license are done mainly due to non-conforming specification or shortfalls in the measurement of premises. The Shop on which licence application is filed must be an independent and a pucca structure, wholly in control and possession of the applicant. The requirement of the premises for wholesale or retail drug license is different. Following is the tabular presentation on the specific condition for premises.
| Eligibility criteria | For Retail Drug License | For Wholesale Drug License |
|---|---|---|
| Type of Premises | A retail pharmacy shop may be located in a Mixed Land Use Area or a Commercial Place. | A wholesale pharmacy store only at a Commercial Place. |
| Minimum Area | The carpet area of the retail store pharmacy must be a minimum of 10 square meters with a height of 2.75 meters. | The carpet area of the wholesale pharmacy must be a minimum of 10 square meters and height of 2.75 meters. |
| Approach Road | It must be facing a minimum road width prescribed by the municipality of the area for mixed land use. | The road/street on which it is located must be broad enough to facilitate loading and unloading of goods. It is suggestable to have a premises facing a minimum road width of 18 mts or more. |
| Furniture | The Retail Store requires
| The Retail Store requires
|
| Equipments | Following equipment/appliances is required for retail sale store
| Following equipment/appliances is required for retail sale store
|
If you are planning to start a drug business, you need to know the regulatory requirements. The stepwise process for a startup in the drug could be as under
A drug licence, once granted, is valid for five years unless suspended and cancelled by the Drug department. The licence imposes certain conditions on the licensee. A wholesale / Retailer of drug having a drug licence shall
