No person can start or continue a business of drugs or cosmetics in India without an appropriate license is obtained for the conduct of such activity. This license in India is granted by the competent authority under the drug and cosmetic act 1940. The provision related to drug licenses in drug and cosmetic act 1940 is extended all over India.
To carry out a business dealing with drug or cosmetic under the purview of drug & cosmetic act 1940 all type of drug or cosmetic business is covered including Allopathic, Homeopathic, Ayurvedic or Unani drugs. Maintaining the quality of Drugs and cosmetics is the responsibility of all persons dealing with it. Any harm or damage occurred after consuming drug or cosmetic and it's proved that the damage was due to the negligence of the manufacturer or seller, it is categorized as the offense, which is tribal as an offense of grievous hurt under IPC.
To start a business of drugs and cosmetics in India it is mandatory to obtain a drug license. The basic feature of drug license:
There are different types of drug license and it depends on the kind of business activity. For obtaining the drug license, an application is required to be submitted by the applicant to the drug controller. The application must contain correct information along with the necessary documents as per the guidelines of the drug & cosmetic rule. Prior to applying for obtaining a drug license, the applicant should contact the duty officer at the mail receipt counter of the Drug Control Department for any guidance or information.
Drug control organization issues two types of license, out of which one is Retail Drug License (RDL) to run a chemist shop. It is issued to only those persons who possess a degree or diploma in pharmacy from a recognized university. And other is Wholesale Drug License (WDL) which is issued to a person who is engaged in the business of wholesale drugs and medicines.
Drug license is classified as follows:
1. Manufacturing License-To produces allopathic or homeopathic drugs and cosmetics can be granted only in recognized industrial areas.
2. Selling License- further, it is categorized into:
a. Retail Drug License
b. Wholesale Drug license
1. Obtain user ID and Password by giving a request letter in person with the details of the firm.
2. All the documents should be scanned in 100 dpi & black and white, and then should be uploaded using the said ID and Password at space provided for the purpose.
3. Please show all the original documents to the inspector at the time of inspection.
4. Please be sure that, all the information is filled precisely for the respective application mentioned below and only then re-send the application. Due to incomplete information application got rejected then application paid fees will be forfeited.
5. Authority may ask for further clarification or other specific documents as per requirement.
6. These guidelines are subject to change as and when required and will be notified from time to time.
7. Application need to be digitally signed by the applicant
8. If the proprietor/ partner is changed, it will be treated as a ‘change in the constitution’ and the applicant will have to obtain a fresh license.
9. After the grant or rejection of your application, you will receive an SMS about the same. Take a print out of the fresh license and renewal approval/rejection option from 'Print License' and click 'MISC approvals' for further approvals within 3 days. With the valid e-signature and official seal, you will obtain licenses/approvals.
10. Registered Pharmacists are also required to update their details by obtaining a separate password.
Here are the following requirements for obtaining drug license:
The minimum area to set up a medical shop or pharmacy is 10 square meters. In case store business combination with the retail & wholesale then the minimum area of 15 square meters is required.
It is required to have a refrigerator and air conditioner on the premises because some drugs such as vaccines, insulin injections, etc. are needed to be stored in the fridge.
Documents required Fresh Application of Retail/Wholesale license :
1. Online fee deposit receipts.
2. Application Form No. 19/19A/19B/19C as applicable (System Generated)
3. Layout plan and key plan of the premises.
4. Constitution of the firm viz: Memorandum and articles of association and Copy of resolution Passed, in case of the company. Deed of partnership, duly attested by Notary Public, in case of the partnership firm. Trust deed, in case of trust/society.
5. Photo ID proof of proprietor/partner/director of the firm.
6. Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
7. Affidavit regarding the compliance of MPD 2021.
8. Registration / Conversion charge /Parking charge receipt issued by MCD with relevant documents in support of commercial use as per MPD 2021 viz; document indicating the Name of notified commercial / mixed-use road/street.
9. The affidavit from the Regd. pharmacist/competent person (System Generated)
For Retail Sale Registered Pharmacist should be:
a. Qualification Proof that is Degree certificate / provisional certificate with mark sheets.
b. Registration Pharmacy Council,
c. Appointment Letter and Bio-data
For Wholesale Licence Pharmacist person:
a. Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets
b. Experience Certificate,
c. Appointment Letter, and Bio-data.
For Manufacturing License
Application for grant or renewal of Drug Manufacturing license. ( application should be made in form 24/ 27)
Required Documents are:
1. Covering letter along with payment of application fee
2. Self-assessed checklist of documents
3. Form 24 & 27
4. Product list
5. List of excipients
6. Similar product
7. Draft label
8. Methods of analysis
9. Additional information form
10. Copy of memorandum of articles
11. List of directors with their address
Under chapter III of drug and cosmetics act 1940 & Part IV of Drug & Cosmetics rule, 1945 regulated the import of drugs in India. As per the requirement of rule 24, A & 24 of drug and cosmetics rule 1945 the application is processed.
The applicant needs to get registered first through form-40 and registration will remain valid for 3 years and after obtaining registration applicant needs to apply for import license in form 8.
1. Cover Letter clearly stating the intent of application duly signed by the applicant
2. As per Rule 37, whether the Drug is patent and propriety medicine (if Yes provide related detail)
3. A copy of Valid Registration Certificate for import of drug in Bulk quantity
4. A copy of Valid Form 10 License for import of drug in Bulk quantity
5. A copy of Valid Manufacturing License for the activity performed, viz., Filling/Packing/Labelling
6. Original labels for Bulk Container
7. Original labels for an innermost and outer carton of the finished formulation
8. S.O.P employed for assigning the Shelf Life to the product
9. Hold Time Stability data to justify the hold time period/transport duration/temperature excursions
We share the detailed and reasonable estimated costs, documents and prerequisites for the complete process before starting the process to ensure transparency.
Our team warrants hassle free documentation. We collect the necessary documents and share the relevant drafts to ensure a timely filing and delivery.
Upon collecting the necessary documents and information, we waste no time in preparation and filing of your application. development on your application is brought to your attention.
On successful completion of the case we share all the relevant documents electronically and physically along with an assurance to pay you back if something is wrong.
India is at a stage where the Internet is becoming a new standard. Consequently, many telecom firms are emerging because of the prospects that can be found. Therefore the government is more than eager to give ISP license (Internet Service Provider)
Everyone wants to expand their company outside the boundaries of the domestic market in this era of cut-throat competition. But doing business worldwide isn't just a cup of tea for everyone. In India, for making export or import to another country the con
Under Food Safety and Standards Act, 2006 establishes authority known as FSSAI (stands for Food Safety and Standard Authority of India); this act consolidates various acts & orders that have to handle food-related issues in various Ministries
All those businesses which operate commercially even if it operates form home needs get registered under shops and establishment as per the applicable rule and regulation of the state concerned act. This act comes in to the existence in year 2016 .
Ayush Licensd in required by every person engaged in manufacture, Retail, Wholesale, or any other form of trade of Ayurvedic, Herbal, Unani or Siddha Products. Ayurveda which literally means “The Science of Life” is one of the oldest healing science
The Factories Act 1948 states that a factory must obtain approval from the labor and employment department for its building plan before it covers itself for registration of a factory. Under this act, Factory license registration
Telecom services are a very crucial factor for the social and economic development of a nation. In this extraordinary growth trajectory Telecommunications is expected to play a pivotal role, by contributing more than 50% to the Digital Economy.
No person can start or continue a business of drugs or cosmetics in India without an appropriate license is obtained for the conduct of such activity. This license in India is granted by the competent authority under the drug and cosmetic act 1940.
The Drugs & Cosmetics Act of 1940 regulates the registration of cosmetics in India, which describes the term 'cosmetic' exclusively as an 'article intended to be, poured, sprinkled or sprayed on or otherwise applied to any human body
A promise to create a culture of quality, patient safety, efficiency and accountability towards patient care. Setting up protocols and policies as per International /National Standards for patient care, medication management, consent process,
To run an Eating House in India, the entity must obtain the Eating House License from the supervisory authority. An applicant will apply to the State Police Headquarters and the town's Police Chief for Eating House License.
An issued Health Trade license is valid for one year and application for renewal must be filed before thirty days (30 days) of expiry date. For renewal same application will be filed after selection of renewal option and for renewal one additional documen
The fire department NOC is provided by the fire departments of the specific state after having confirmed and tested the whole building resistance to fire, i.e. the building is fireproof and can prevent fire-related incidents. Upon verification of an appl
A trade license is a document/certificate that gives the applicant (person seeking to open a business) permission to start a specific trade or business in a given area/location. The license does not, however, authorize the holder to conduct any other trad
Central Ground Water Authority is constituted by the government of India under the Environmental (Protection) act 1986. It is established to regulate and control the development and management of groundwater resources in the country.
Accreditation is the formal certification, authorisation and registration of a laboratory which has proven its capacity, competence and reputation to perform the tasks it claims to be able to perform.
Discover the comprehensive guide to obtaining an MD-15 license for importing medical devices in India. Explore device classification, regulatory requirements, and documentation needed to navigate the process smoothly. Form MD 14 & MD 15
PSARA License is a prerequisite before any person in India starts a private security company. The Private Security Agency is an entity involved in providing security guards and other related services as an alternate to the police at an establishment.
Objectives The purpose of the 1970 Contract Labour Regulation and Abolition Act is to prevent the exploitation of contract labour, as well as to introduce better working conditions. A worker is considered to be employed as a Contract Labour when recruite
Tea is one of the industries that come under the jurisdiction of the Union Govt through an Act of Parliament. The genesis of India's Tea Board goes back to the passage of the Indian Tea Cess Bill in 1903. The Bill provided for a levying a cess on tea expo
A comprehensive guide to obtaining a Wholesale Drug License in India, covering the Drugs and Cosmetics Act, types of licenses, application process, benefits, and penalties.
Uniquely repurpose strategic core competencies with progressive content. Assertively transition ethical imperatives and collaborative manufactured products.Write About Us
© 2023 Corpzo Ventures Private Limited.