Today, India has become the leading producer of generic medicine globally. The pharma sector is proliferating in the country, and it is estimated that the growth will hike in the upcoming year. So, if you are thinking of stepping into the pharma industry, then there are certain things that you should know before setting up a pharma company. The pharma company is a bit more complex to set up than other manufacturing units as it involves people’s health. A capsule manufacturer in India has to comply with many rules and regulations.
What are the rules and regulations that you have to follow to set up a pharma unit? Then this article is for you as in this article, we have explained all the rules and regulations that a capsule manufacturer should know before starting the company.
Indian Regulations
Factory Act Regulations
If you are setting up a pharmaceutical manufacturing unit with more than ten workers, you have to register your company under Factory Act, 1948. It may vary from state to state as state governments are allowed to make rules under the factory act, so remember to check your state rules and regulations of this act.
You can contact the state concern Inspector with approval and information about the factory set-up rules in your state.
CDSCO
Central Drugs Standard Control Organizations (CDSCO) regulate drugs and medical devices in India. It provides information about the medicine’s regulatory requirements in India.
D & C Act 1940
The Drug and Cosmetics Act regulates India’s manufacturing, import & export, sales, and distribution, so it’s relevant to know about it.
The Drugs and Magic Remedies Act
It controls the advertisements of medicines and prohibits the advertisements of magic remedies containing drugs.
WHO Guidelines
WHO has provided guidelines on safety & quality, supply & management, the use of medicines, and medicines policies are needed to follow; it will increase the credibility of your brand.
These are some crucial facts that a capsule manufacturer in India should know to set up a drug manufacturing company.
You have to get a Drug Manufacturing license and know about the Good manufacturing requirements.
List of required licenses for a pharmaceutical company in India
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Company registration
For company registration, choose an appropriate and unique name and decide the type of manufacturing company like ayurvedic or modern medicine.
Register under Company Act 1965 or company act 2013. If you are setting up a
partnership firm, you need to register under the Limited Liability partnership Act 1932.
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Drug Manufacturing License
For drug manufacturing, a pharma manufacturer needs to get a drug manufacturing license issued by a state drug controller under the Drug Controller General of India (DCGI).
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Drug Distribution License
In India, a capsule manufacturer needs to get a drug distribution license to distribute and sell finished products. You need to get a wholesale drug license through the State Drug Inspector.
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Goods and Services Tax Registration
The tax registration is crucial for any business for manufacturing and selling. In India, all companies and services come under GST, so it is essential to register a GST identification number.
Final Thoughts
The pharma industry is full of opportunities in India, and for setting up a pharma-related business, you need to follow the rules and regulations of the country.
