Starting a pharmacy in Delhi requires more than renting a shop and stocking medicines. A pharmacy dealing in medicines must comply with the applicable requirements under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, along with Delhi-specific requirements administered by the Department of Drugs Control, Government of NCT of Delhi. The exact licence depends on whether the business operates as a retail pharmacy, wholesale distributor or both.
At Remind Legal LLP, we assist entrepreneurs with business registration, drug licence applications, documentation and other applicable regulatory compliances required to establish a pharmacy in Delhi.
Planning to start a pharmacy in Delhi? Get professional assistance with the applicable registration and licensing process.
A pharmacy deals directly with medicines, making regulatory compliance particularly important. Selling, stocking or distributing drugs without the appropriate licence can expose the business to regulatory action and other legal risks.
Delhi's Drugs Control Department specifies separate licensing requirements for retail and wholesale sale of drugs. It also requires suitable premises and, for retail sale, a registered pharmacist registered with the Delhi Pharmacy Council.
Completing the applicable registrations and ensuring proper storage, documentation and professional supervision help a pharmacy operate legally while building trust and confidence among customers, healthcare professionals and the suppliers.
Step 1: Choose the Right Business Structure
First, select an appropriate and suitable business structure based on ownership, liability, investment and future expansion plans.
Common options include: -
The chosen structure will also determine the documents required for the drug licence application.
Step 2: Obtain PAN
Obtain a Permanent Account Number (PAN) for the business or proprietor, as applicable. PAN is required for taxation, banking and various business-related transactions.
Step 3: Obtain TAN (Where Applicable)
If the pharmacy is required to deduct tax at source under applicable income-tax provisions, it should obtain a Tax Deduction and Collection Account Number (TAN).
Step 4: Open a Current Bank Account
Open a dedicated current account in the name of the business. It helps separate business and personal finances and facilitates payments to medicine suppliers and other vendors.
Step 5: GST Registration (Where Applicable)
GST Registration should be obtained where required under the applicable GST provisions. The requirement should be determined based on the nature and type of the pharmacy's supplies, turnover and various other relevant circumstances.
Step 6: Obtain the Appropriate Retail Drug Licence
This is the core regulatory requirement for a retail pharmacy.
Delhi's Drugs Control Department provides separate retail licences depending on the category of drugs being sold. For example, licences in Form 20 and Form 21 cover specified categories of drugs, while Form 20-F applies to retail sale of drugs specified in Schedule X. The exact licence or combination of licences required should therefore be determined based on the medicines the pharmacy intends to stock and sell.
Applications are made through the prescribed process of the Delhi Drugs Control Department.
Step 7: Appoint a Registered Pharmacist
A retail pharmacy must have a Registered Pharmacist meeting the applicable requirements. The Delhi Drugs Control Department's current requirements include proof of the pharmacist's qualification, valid registration with the Delhi Pharmacy Council, appointment documentation and bio-data.
The pharmacist plays a crucial role in ensuring that the sale and dispensing of medicines are carried out in accordance with applicable requirements.
Step 8: Ensure the Pharmacy Premises Meet the Required Standards
The premises must satisfy the requirements prescribed for the relevant drug licence.
For retail licences in Form 20 or Form 21, Delhi Drugs Control specifies a minimum area of 10 square metres. Where retail and wholesale licences are taken together, the minimum area is 15 square metres. The Department also specifies a minimum height of 2.75 metres and requires the premises to be independent and appropriately accessible.
The premises should also have adequate storage arrangements, including facilities such as refrigeration or cold storage where required for maintaining the stability of medicines.
Step 9: Ensure MPD 2021 and Commercial-Use Compliance
Premises used for a pharmacy must satisfy applicable land-use and commercial-use requirements.
The Delhi Drugs Control Department specifically requires relevant documentation concerning MPD 2021 compliance and, where applicable, MCD conversion charges and documents supporting commercial use. It also states that a drug licence cannot be granted for premises situated on a DDA-allotted residential plot, land or flat unless the applicable MPD 2021 requirements are met.
Therefore, the proposed premises should be checked for applicable commercial, mixed-use or other permitted use before entering into a long-term lease or investing in the premises.
Step 10: Shops & Establishment Compliance (Where Applicable)
Depending on the nature of the establishment and applicable employment requirements, the pharmacy should comply with the laws governing shops and commercial establishments, working conditions and employee-related obligations.
Step 11: Health Trade Licence / Municipal Compliance (Where Applicable)
Depending on the premises, business activity and applicable municipal requirements, additional municipal compliance may apply.
The pharmacy should verify the current requirements of the concerned municipal authority rather than assuming that a separate municipal licence is universally required in every case.
Step 12: Udyam (MSME) Registration (Optional but Recommended)
Eligible pharmacy businesses may obtain the Udyam Registration under the MSME framework.
Although it is not a substitute for the Drug Licence, it may help eligible businesses access applicable government schemes and other MSME-related benefits.
Step 13: Labour Law Compliance (Where Applicable)
If the pharmacy employs the sales staff, pharmacists, delivery personnel, accountants or various other employees, it should comply with the applicable labour and employment laws.
The exact and accurate requirements depend on various factors such as employee strength and the nature of employment.
Step 14: EPF Registration (Where Applicable)
If the pharmacy falls within the applicability of the Employees' Provident Funds and Miscellaneous Provisions Act, 1952, EPF Registration and related compliance may be required.
Step 15: ESI Registration (Where Applicable)
If the establishment is covered under the Employees' State Insurance Act, 1948, ESI Registration and applicable employee-related compliances should be completed.
Step 16: Trademark Registration (Optional but Recommended)
Trademark Registration is basically not mandatory for starting a pharmacy, but it can help protect the pharmacy's name, logo and brand identity.
Registering the brand can be particularly useful if you plan to expand into multiple outlets or develop an online pharmacy brand in the future.
Step 17: Wholesale Drug Licence (Where Applicable)
If the business intends to sell medicines on a wholesale basis, an appropriate wholesale drug licence is required.
Delhi Drugs Control separately provides wholesale licences such as Form 20-B and Form 21-B. The applicable licence depends on the categories of drugs involved.
A wholesale operation also has requirements concerning the person responsible for the business, including the applicable competent person requirements.
A retail pharmacy that does not undertake wholesale activities does not need to obtain a wholesale licence merely because it holds a retail Drug Licence.
Step 18: Additional Drug Licences and Activity-Specific Approvals (Where Applicable)
Depending on the products handled and activities undertaken, additional regulatory requirements may apply.
Schedule X Drugs
If the pharmacy intends to sell or stock Schedule X drugs, the applicable Form 20-F retail licence or other relevant licence must be obtained, along with the additional storage, record-keeping and sale requirements applicable to such drugs.
Homoeopathic Medicines
If the business intends to operate a homoeopathic pharmacy, the applicable homoeopathic drug-sale licensing requirements should be considered. Delhi Drugs Control separately lists Forms 20-C and 20-D for homoeopathic retail and wholesale licences.
Narcotic and Psychotropic Medicines Compliance
If the pharmacy stocks or dispenses medicines subject to the additional controls under the NDPS Act and applicable drug laws, it must follow the relevant licensing, storage, record-keeping and the dispensing requirements.
A normal pharmacy does not require FSSAI registration merely because it sells medicines. However, if the business separately handles food products or other products covered by food-safety legislation, the applicable FSSAI requirement should be evaluated.
Where the pharmacy's activities involve products or packaged commodities covered by applicable Legal Metrology requirements, the relevant compliance should be completed.
Depending on the building, premises, occupancy and applicable fire-safety requirements, a Fire Safety NOC or other fire-safety compliance may be required.
A standard retail pharmacy should not automatically be treated as a biomedical-waste-generating healthcare establishment. However, if the business undertakes the additional healthcare activities that generate biomedical waste, the applicable Biomedical Waste Management requirements should be assessed.
Common documents may include: -
Proper registration and licensing can help your pharmacy: -
Estimated Timeline
The timeline for starting a pharmacy depends on the business structure, readiness of the premises, availability of a registered pharmacist, completeness of documents and processing by the concerned authorities.
Drug-licence applications may require inspection or verification as part of the applicable regulatory process. Therefore, the applicants should avoid committing to a launch date until the necessary approvals and premises-related requirements have been addressed.
Government Fees
Government fees depend on the type of Drug Licence and other registrations or approvals applicable to the pharmacy. The Professional fees will depend on the scope of assistance required.
Applicants should verify the applicable government fee at the time of filing because fee structures and procedural requirements may change.
Starting a pharmacy requires careful coordination between business registration, premises compliance, professional requirements and drug-sale licensing. A mistake in the premises, pharmacist documentation or licence category can delay the application process.
Remind Legal LLP provides end-to-end legal and compliance assistance for entrepreneurs planning to establish pharmacies in Delhi.
Our Services Include: -
Whether you plan to establish a neighbourhood pharmacy, retail chemist shop, wholesale medicine business or retail-cum-wholesale operation, our team can assist you with the applicable registrations and regulatory requirements.
Ready to start your pharmacy in Delhi? Contact Remind Legal LLP for professional registration and compliance assistance.