Pharmacy is one of those business areas that witness long term profitability irrespective of the economic turbulence. The drug business is relativity more rigid and versatile than other business models when it comes to withstanding the financial crisis. Any business entities willing to engage with such a business model need to avail of a drug license as it is a mandatory requirement. Unlike other registrations in India, the provisions of the drug license are comparatively more stringent.
The government mandates the drug license for those who want to produce or sells drugs in India within a legal framework. If you are skeptical about this business model and have some doubt regarding its provision, take a step back and go through the following section, which illustrates the benefits of drug license in India.
Ensure better Quality of Vaccination
Keeping an individual’s health and safety in view, the regulatory authorities have deployed some extensive and stringent guidelines for the drug producers in India as per the Drug and Cosmetic Act, 1940. The Act encompasses diverse guidelines that are supposed to ensure the drug’s quality as per the predetermined standards. The entities with the drug license are committed to render high-quality medicines to the consumer irrespective of the operating conditions. Before dispensing the medication to the buyer, the manufacturer needs to ensure that every batch of the vaccination is properly marked with a pricing and ingredient table. It is one of the prominent benefits of Drug license in India.
Read our article:How to Obtain Drug License in India?
Prevent Adulteration
Adulteration is a common practice that has been hampering the drug’s authenticity for ages. After the deployment of the Drug and Cosmetic Act, 1940, the government has limited the scope of adulteration by imposing heavy penalties on the defaulters. The drug license holders need to maintain a strategic distance from these sorts of practices to avert penalties prescribed in the bylaws. Hence, the drug license ensures that the drugs from the specific manufacturers are authentic in every aspect, and buyers can consume it without any skepticism. It is perhaps one of the most refined benefits of Drug license.
Discourages Prohibited Drugs
Drug and Cosmetic Act, 1940[1], has laid down extensive guidelines for the import of drugs in India. No registered importer can buyout the vaccination from the overseas buyers that are prohibited or don’t contain any therapeutic value. Hence, entities under the drug license are not liable to import the medication mention in the list of banned vaccination. If the authority has a strong reason to believe that a particular drug is not potent enough to cure the disease, they can ban the drug on the shorter notice. As long as entities maintain the compliance’s integrity, they can grow their business seamlessly without facing any penal provisions.
Ensure fair Pricing on Drugs
Well, the margin for error in a drug industry is next to negligible. The Act governing the drug license won’t allow the manufacturers, wholesalers, and retailers to charge the unfair pricing on the drug’s trading. There is no denying that unfair pricing can undermine the business in the long run. Keeping this thing in mind, the government has already set a framework that ensures the transparency on pricing within business fraternity. It is one of those advantages that outshine other benefits of Drug license with ease.
For seamless registration of the license, head over the online portal of Food Safety And Drug Administration. The online application seeks some mandatary documentations that you need to upload in the form of a soft copy. Further, the portal will guide you through the payment gateway for the submission of the fee.
Once done, the portal will provide the option of generating the challan against the submitted application. You will need this challan for further processing. Once the form is dropped at the disposal of the authority, they will conduct the investigation of the same on prescribed norms. Keep in mind that onsite inspection is a part of this licensing process in which an authorized person will visit at the business premises and inspect it as per the bylaws. Once all the conditions are met, the authority will confer the license to the applicant.
Key points regarding Drug License
- Obtaining a drug license is a basic requirement for the entities engaged with the manufacturing and distribution of the vaccination in India.
- Drug license serves the different purpose for Wholesaler, Retailer, and manufacturer.
- In the case of infringement of bylaws, the entities would no longer continue their business operation until further notice.
- The manufacturer under drug license needs to stay away for adulteration to avert stringent penalties.
- The penal provisions also include the imprisonment of one year in case of adulteration or unfair business practice.
- The application of a drug license is available on the online portal of the concerning authority.
- While catering to the online application, the applicant needs to upload the requested document in the form of a soft copy.
- Portal encloses a payment gateway, which allows the applicant to submit the application fee.
Conclusion
Drug license cites guidelines that outline the working protocols of the drug’s producer and seller. The contravention of bylaws w.r.t drug license could jeopardize the existence of the business entities working in the pharmaceutical sector. Having a drug license can let you avail of several benefits and isolate your business from prominent penalties. For more information, feel free to get in touch with CorpBiz helpdesk, where you can avail professional assistance on compliance and registration-related matters from the experienced and proactive experts.
Read our article:How one can apply for Wholesale Drug License in India?
