How to Get a Manufacturing License of Drugs in India?
How to Get a Manufacturing License of Drugs in India? – Are you planning to establish your own business in the pharma sector? Do you want to know the exact procedure to obtain a Drug Manufacturing License? If yes, then this blog will clear all your doubts. A Manufacturing License for, Drugs authorizes Indian nationals who are interested in starting their own business to deal with domestic medicine, drug, and cosmetic medicines. So, if you are trying to obtain a Manufacturing License of Drugs but are unaware of the process, then do read this blog till the end. In this write-up, we will tell you How to Get a Manufacturing License of Drugs in India.
The Manufacturing License of Drugs will keep you and your business protected against legal proceedings. This application is made as per Rule 27 of the State Drugs Licensing Authority, CDSCO (Central Drugs Standards Control Organizations), and DCGI (Drugs Controller General of India). That is why having the Manufacturing License for Drugs is necessary for a country, especially India. If you want to apply for Manufacturing License for Drugs, then you have reached the right place. Coming up are the steps that will show you How to Get a Manufacturing License of Drugs in India.
Procedure for Getting a Manufacturing License for Drugs in India
The accurate procedure for getting a Drug Manufacturing License is as follows:
- The applicant can apply for the license online to the State Drugs Controller. The documents should be uploaded and then to be dispatched to the Drug Controller Officer.
- The individual should make an application in the mandatory form details.
- After filling out the application, the applicant should submit the application to the State Drugs Controller along with the necessary documents.
- Subsequently, the application form would be inspected, and then it is further forwarded to the Senior Drug Control Officer of the respective area for the scrutiny of the premises.
- If all the adhere to the business conditions, the license is granted by State Drugs Controller and it is notified to the applicant through the medium of SMS or email.
Documents Required for a Drug Manufacturing License in India
- A mandatory application form is to be filled out online.
- Layout with site plan of the premises appropriately signed by the Proprietor, Partner, or Director of the firm.
- Original or attested Xerox of Receipt of the Rent or Lease Deed of the premises.
- Validated Photostat of the partnership deed if it is an alliance firm or MOA and AOA if it is the sole firm or company is accurately registered by directors.
- Record of current directors along with their names and residential address.
- Complete details of the technical staff or registered people with photocopies of their educational qualifications, experience, and registration certificates.
- Non-conviction testimony of legalized technical staff as needed with speculative qualification and validations.
- Verified copies of technical staff approval and academic qualification as per the conditions of the Drugs and Cosmetics Act 1940 and Rules 1945.
- List of machinery and laboratory devices.
- Original or Attested Copies of purchase bills of the machinery and equipment.
- No Objection Certificate (NOC)
- Evidence of load ratification.
- Validated copy of Occupation Certificate Form
- Verdict of Board of Directors in regard to the appointment of the accredited notary.
- Non-Conviction affidavit by the accredited notary in case of any appointed firm.
Benefits of Getting the Manufacturing License of Drugs
Getting a manufacturing license of drugs comes with manifold benefits that will help the individual to earn a great amount of trust and respect in the pharmaceutical market. Having a license from authorities can help you in many ways. It is not a matter of choice but a compulsion to run your successful business with medicines and drugs. Here are the remunerative benefits of getting a Manufacturing Drug License:
Credibility Proof
A Manufacturing Drug License plays a vital role in the pharma sector as it acts as proof of credibility and reliability and frames a substantial image of the company.
Legitimacy
As it is against the law to engage in the manufacturing or marketing of drugs in India without acquiring a license, getting a Manufacturing Drug License provides legitimacy to the business.
Accurate Monitoring and Management by the Authority
Another benefit of obtaining a Manufacturing Drug License is that it assists the authority in monitoring and managing the sales of drugs in India which eventually enhances business creditability and authenticity.
Costumers’ Confidence and Trust
A Manufacturing Drug License Certificate provides evidence to the consumers that the business is following strict quality standards while manufacturing the medicines. Moreover, an authoritative license proves to the consumers that the drugs are safe, approved, high-quality, and free from side effects.
Conclusion
Now that you understand the procedure of How to Get a Manufacturing License of Drugs in India, you should definitely take it into undertaking if you want to enter the Indian Pharmaceutical Industry. The entity should be attentive to the proposed drug if it is certified as a drug or new drug. It is because there are several sets of rules and regulations for drugs. If you want to know further information about the prospects of the Manufacturing License of Drug or if you need genuine assistance for business registration, then without any second thought, contact Saphnix Lifesciences.
