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Medicine are important for the good health of a Nation. The drugs are different from other commodities, so the government has made some stringent laws. In the Drugs and Cosmetics Act, 1940, the regulations related to the manufacturer and sale of drugs are shared.
The authority has full control over drugs from the raw material to final distribution. Until then, it should be recommended to the consumer or patient only through the pharmacist in a retail pharmacy, Hospital or Dispensary.
The medical store must register the store as per the type of business. The medical store registration is also known as a drug shop license. In the article, the benefits and types of drug licences and types of medical stores are shared.
The Drug Control Department issues drug licenses, for instance, the Delhi Drug Control Department issues licenses in Delhi. Similarly, the departments of other states issue licenses as per their guidelines. The department of Delhi is divided into two divisions to enforce the drug laws. Two zones make each division that is led by a Drugs Controller. The divisions are as follows:
The Drug and Cosmetic Act of 1940 and 1945 made it mandatory for everyone involved in the manufacturing, distribution and selling of drugs to obtain a drug license. In this, the companies provide detailed information about their products, dosage, ingredients, warnings and side effects with other drugs and foods.
Having a drug license is important for businesses because of multiple reasons. Some of the reasons for obtaining a drug licence are as follows:
The business has to follow the compliances and do the business operations ethically. If you have a valid license, then it protects you from penalties and legal disputes. The authority checks whether you are adhering to the regulations of the drug license or not.
In case, you operate without a drug shop license, then you have to follow the consequences. To operate a business for the long term, adhering to the compliances is required.
The drug license acts as a system to ensure overall quality control and minimise the risk of unsafe or ineffective drugs. As the licensing process has strict regulations and manufacturing practices, businesses should follow all the rules and regulations. Regular inspections of products to reduce the chances of uncertain risks.
In the drug business, patient safety is the priority of the pharmaceutical sector. The license for the medication store is used as a tool against the substandard medications, that act as a barrier for unethical practices. It promotes dispensing practices to enhance patient safety.
However, the strict licensing requirements and regular inspections help in minimising poor manufacturing. Also, stop the contaminated drugs from entering the market.
Some jurisdictions require a drug license for the import and export of pharmaceuticals. By having a licence, businesses can enter into international markets and expand their business reach.
The licensed drugs have a unique batch identification number that helps in tracing the drugs throughout the supply chain. However, the businesses must report any adverse events associated with the drugs to the related authority.
The following are the types of medical stores that an individual can start:
The individuals must decide the type of medical store, before setting up and applying for registration. There are multiple types of drug licenses that you require as a medical store and these licenses are:
The government grant this license to businesses that buy, store or sell drugs wholesale to other licensed entities such as pharmacies, hospitals and clinics. It works as a middleman between the drug manufacturers and the final consumers.
The type of license can differ as per the drug type covered such as allopathic, homeopathic and ayurvedic. Other than this, the activities that are permitted are storage, distribution and export.
To manufacture the drugs, the businesses are required a manufacturing license. This license allows both manufacturing and distribution of drugs on a large scale. To obtain a manufacturing drug license, businesses have to follow complex regulatory standards as compared to other licenses.
A retail license is required to set up and run a medical store or pharmacy store. However, a pharmacy license is required to operate a medical store. The appointed pharmacists must be qualified pharmacists with a degree of B. Pharmacy and M. Pharmacy. Only qualified pharmacists can secure a pharmacy license.
To conclude, a drug license is essential for selling and manufacturing drugs. In case, the business did not have the licence and it is commencing the business. Then it can lead to serious troubles with the authorities. So to set up a medical store or any other type of drug business, obtain a license.
At Registrationwala, assist our clients in getting a drug licence. We take care of complete paperwork and follow all compliance. Reach out to us, if you have any queries regarding the drug license.
Hey there, I'm Dushyant Sharma. With the extensive knowledge I've gained in past 8 years, I have been creating content on various subjects such as banking, insurance, telecom, and all the important registration and licensing processes for various companies. I'm here to help everyone with my expertise in these areas through my articles.
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