Meghalaya Drug License
Meghalaya Drug License
Meghalaya drug license is a document of permission for carrying out businesses related to drugs, medicines and cosmetics. The government of Meghalaya issues drug license to regulate the manufacture, storage, distribution and sales of drugs. Meghalaya drug license is issued under the Drug and Cosmetics Act, 1940 to a person dealing with drugs. As per this act, it is mandatory to obtain a Meghalaya drug license before the launching a drug business. In this article, we look at the procedure for obtaining a Meghalaya drug license in detail.
Know more about How to start a pharmacy business
Drugs and Cosmetics Act
Meghalaya drug license is a crucial document according to the Drugs and Cosmetics Act, 1940. This act moderates the manufacture, distribution import and sale of drugs and cosmetics, which includes allopathic drugs, homoeopathic medicines, and even the Ayurvedic, Siddha or Unani drugs.
Importance of Meghalaya Drug license
Some of the significance of Meghalaya drug license is explained in detail below:
- The Meghalaya drug license permits market, manufacture sale, resale, trade of drug and cosmetics.
- Without a Meghalaya drug license, no person can do pharmacy business or even start to associate with any dealings in Meghalaya.
- For protecting good health of India through adequately accessing the medicines and drugs, the Drugs and Cosmetics act made it mandatory for obtaining a drug license
- Meghalaya drug license also ensure that the drug and drugs are not misused or abused by any individuals in Meghalaya
- Dealing with drugs/medicines a without a drug license is a cognizable offence. Every trader in the pharmacy industry needs to have their drug incense to carry out their day-to-day business work.
- Meghalaya drug license contains the rule and regulation for the person who is dealing with drugs business
Note: It is the responsibility of all individual dealing with drugs and cosmetics to maintain its quality. If any person consuming a drug or medicine suffers any harm from the negligence on the part of the seller or manufacturer of the medicine, the same is an offence, which is an offence of grievous hurt under IPC. Hence holding Meghalaya drug license is necessary.
Who needs Meghalaya Drug License?
Meghalaya drug license is crucial for dealing with the following type of business. Any proprietorship, partnership firm, limited liability company, company or business firm located In Meghalaya and is physically distributing the medicine in the state is required to hold a drug license:
- Business with any cosmetics intended to be sprinkled, rubbed, poured or introduced into the human body or for beautifying, cleansing, promoting attractiveness, or altering the appearance of a human, must obtain Meghalaya Drug license.
- It is vital to get a drug license to deal with the drug which is used for internal or external in human beings
- Manufacturing and distribution drugs or cosmetics applied to the human body to repel insects like mosquitoes also need Meghalaya drug license.
- Business with drugs used for the destruction or insects which cause diseases in human beings must get a drug license.
- Meghalaya drug license also mandatory for dealing with empty gelatin capsule.
- To manufacture, store and distribute the drugs used for diagnosis, mitigation, treatment or prevention of disease or disorder in humans or animal, need Meghalaya drug license
Click here to know more about the Medicine and drugs allowed for import without a licence
Basic Requirement for Obtaining Meghalaya Drug License
According to the provision of Drug and cosmetics act, to get a Meghalaya drug license the below-described requirements to be met by the trader.
The minimum area required for setting up a medical shop or pharmacy is ten square meter. In case of the store business combination with the wholesale and retail of drugs then the minimum area of fifteen square meters is required. License for the sale of drugs can be issued in the commercial premises or other premises independent of residence.
It is crucial to have an air conditioner and refrigerator on the premises because some medicines such as insulin injections, vaccines are needed to be stored in the refrigerator.
Sale of drugs should be carried in the presence of a registered Pharmacist approved by the Meghalaya Government who is required throughout the working hours in the retail shop.
The wholesale of drugs can be made either by a registered pharmacist or any competent authority who graduate and having experience in drugs or in the presence of an of person who has passed SSLC having experience of four years in drugs/medicines business, specially approved by Health and Family Welfare Department.
Classification of Meghalaya Drug License
Based on the requirement of the pharma business, Meghalaya Drug License can be classified in the following categories:
- Sale License
- Manufacturing License
Sale license is issued to persons or agencies engaged in the sale of drugs or medicines in Meghalaya. The sale drug license is further classified into the following two types.
- Retail License: It is granted to run and sell drugs or drug products in Meghalaya.
- Wholesales License: It is provided to a person or agency engaged in wholesale of medicine or drugs
Manufacturing license is granted to a person or agencies involved in the manufacturing of drugs, medicines and cosmetics. The government of Meghalaya also issued Manufacturing loan license.
The health and family welfare department, Government of Meghalaya, issues drug license as per the provisions of drug and cosmetics act. The prescribed authority for issuing Meghalaya drug license is the Director of Health Services.
Meghalaya drug license will be issued within 45 days from the date of application.
The Meghalaya drug license granted to carry out business related to the drug is valid for four years from the date of issue. After expiry, the license can be renewed.
Documents required for Obtaining Meghalaya Drug license is as follows:
Documents for New Sale Drug License
- Applications in the prescribed form
- Wholesale license copy
- Challan of rupees as prescribed to be paid under the correct head of account
- Approved plan copy
- Draft labels
- Meghalaya Sale Tax Clearance Certificate
- Method of analysis
- Flow sheet
- List of products
- Manufacturing process
- Standard operating procedures
- Stability data for each product
Documents for New Manufacturing Drug License
- Partnership deed or MOA (Memorandum of Article of Association) and List of Directors
- Appointment Letter of the Registered Pharmacist
- Copy of registration certification issued by Meghalaya State Pharmacy Council
- Consent letter of the registered pharmacist with Details of the Previous Service
- Photographs of the Pharmacists
- Renewal Receipt of Meghalaya State Pharmacy Council
- An Affidavit of the pharmacist on Rs.20 Stamp paper
- Rough Sketch of the Premises
- Ration Card or PAN Card or identity card or Aadhar card of all Partners or Directors and Pharmacist
- Rent Receipt for the Premises and necessary proof for the legal possession of the Premises like Copy of the registered Sales Deed
Meghalaya Drug License Application Procedure
The application procedure for obtaining the Meghalaya Drug License is described in detail here:
The government of Meghalaya is prescribed different Forms for Issuance of Manufacturing License According to the Nature of Drugs.
Step 1: The applicant needs to submit the application form along with the documents to The Director of Health Services office.
Application For Sale Drug LicenseSale Application
Application For Manufacturing Drug LicenseManufacturing Application
Step 2: After verifying the documents, the concerned authority will conduct a field level inspection. After verification, drug controller will forward the report to the commissioner.
Note: If you are applying for more than two categories of products, drug controller and district officer will conduct an inspection jointly.
Step 3: The concerned authority reviews the report and submits recommendations to the Director of Health Services. The concerned authority will issue the license. The applicant can get the Meghalaya Director of Health Services office.