DRUG LICENCE : Throughout history, medical advancement has played a vital role in supporting the survival of human beings and curing life-threatening diseases. Medicine is the only weapon with mankind to fight diseases. But medicine is not an ordinary consumable product like chocolate because a particular drug can be used to cure a specific disease. Drugs should be taken with the consultation of a well-educated doctor so that he can advise about how to use when to use, what particular drug to be used to cure the disease; otherwise, it can lead to harmful side effects. The government of Indian has formed an Act which is known as “The Drugs and Cosmetics Act, 1940”. This act provides all the guidelines about the manufacturing, import, distribution, and sale of drugs and cosmetics. This act also covers all the regulations of Ayurveda, Siddha and unani drugs.
Under“The Drugs and Cosmetic Act”, Central Drugs Standard Control Organization (CDSCO) provides the approval for drugs, clinical trials, lay down of the standards of drugs, quality control of drugs etc., with the coordination of the authority.
In December 2020, The Ministry of Health and Family Welfare published the Cosmetic rules 2020 that the licence is a must for the import of cosmetics into India.
“Drugs” -Inpharmacology, a drug is a chemical substance, typically of known structure, which, when administered to a living organism, produces a biological effect.
State Drugs Standards Control Organization (SDSCO) –State Authority with CDSCO is responsible for the grant of licence who deals in the business of Drugs & Cosmetics on the state level. The business operates in different states, drugs sold or stocked for sale in more than one state, a licence is mandatory for each location.
Drugs licence is the permission granted by the Drug controller to deal in drugs. Kinds of the licence depend upon the type of business as follows.
Types of sales Licence are as follows
1. Retail Sale Drug Licence(Chemist Shop) Retail sale refers to the sale of the drugs to the end consumer. Retailers can sell drugs to a hospital, dispensary, medical, education, or research institutes, etc. Under the Drugs and Cosmetic Act, a drugs licence is mandatory for the retailers of drugs or Chemist shops. And a retail licence is issued by the Drug controller Authority of the State.
In case any person sells drugs without the Licence, he shall be punishable with imprisonment for the term of not less than 1 year and may extend up to 3 years with a fine up to Rs. 5000.
Note –If a retailer is indulged in the drugs business in more than 1 state, then a different licence is required for the different state.
2) Whole Sale Drug Licence–A wholesale licence is issued to the company/distributor/independent agent who can be an authorized Indian agent for the local or foreign manufacturer. Or we can say that the wholesale licence is issued to the manufacturer and authorized Indian representative. Whole Sale Drug Licence is issued by the CDSCO for those who deal in wholesale distribution of Drugs.
3) Restricted Licence for Drugs –
Manufacturing licence is granted to the manufacturer of Allopathic and Ayurvedic drugs and cosmetic products; a licence is granted by the concerned State government of the manufacturer.
Types of manufacturing licence
According to the drug and cosmetic act,” A loan license means a license which a licensing authority may issue to an applicant who doesn’t have its own arrangement of manufacturing but who intends to avail himself of the manufacturing facilities of a licensee.
Under Schedule X, Drugs & Cosmetics can be imported to India only after obtaining a Licence. Not only drugs shall be registered, but the manufacturing unit should also be registered for import purposes.
This licence is for those applicants who operate their business in more than one state. Without a multi-drug licence, you cannot sell drugs in more than one state.
30 working Days
Issued Licence is valid for 5 years
Licence can be renewed by providing requisite documents for renewal, and authority will renew the licence for a particular time period.
A drug licence is required to start a pharmacy company. Whether you are a retailer, distributor, or manufacturer of pharmaceuticals and cosmetics in India or abroad, you may contact EVTL INDIA directly for any sort of drug licence. EVTL INDIA ensures that you will receive your licence at an appropriate time, and the licence will increase the reputation of your drugs in the eyes of the public. We are offering a complete solution for drugs manufacturer in obtaining the Licence and testing facility in India.
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