+91 9824382041Which are the most dynamic sectors in India? Well, the answer is a little tough because India has done remarkably well in all fields in the last few decades.
However, if you rate the most promising and flourishing sectors, then it is the pharmaceutical sector.
It is because of the increasing demand for healthcare products and medicine. And other factors are good quality of products, global reach, and support by the government policies.
No wonder, so many skilled professionals are entering the market and testing their fortune.
As far as various business models of the pharma industry are concerned, each model has its pros and cons. One of them is the pharmaceutical manufacturing unit.
If you want to start a leading pcd pharma company in India, then here is how you will do that.
Regulatory landscape
A regulatory framework is important when you set up a pharmaceutical manufacturing company in India.
There are different regulatory bodies such as Central Drugs Standard Control Organization (CDSCO) and Food and Drug Administration (FDA).
They are crucial for compliance and operational success.
CDSCO is responsible for regulating the safety, efficacy, and quality of pharmaceuticals in India. FDA looks after the registration, manufacturing, and distribution of pharmaceutical products.
Licensing Requirements & Compliance
It is mandatory to obtain licenses from CDSCO and state regulatory authorities when you want to launch a pharma manufacturing company.
Also, you need to be compliant with Good Manufacturing Practices (GMP) and other quality standards so that product quality and safety are ensured.
Thirdly, you should implement robust quality management systems and conduct regular audits.
To place your company in the list of top 10 pcd pharma companies in india, compliance and licensing requirements must be fulfilled.
Location and Infrastructure
It is certainly a critical decision to choose the right location for your pharmaceutical manufacturing unit.
The reason is, your location and surrounding infrastructure impacts operational efficiency, cost-effectiveness, and market access.
What you need to look for:
- Infrastructure
- Proximity to transportation hubs, raw material suppliers, and healthcare clusters
- Availability of skilled labor
- Ease of doing business
- Supportive ecosystem
- Storage space
- Manufacturing space
- Availability and repair and maintenance facilities of modern equipment and machinery
- Logistics and faster delivery methods
- Better supply chain
- Minimum risk factors
Obtaining Necessary Approvals
When you launch a pharma manufacturing unit, you need some mandatory approvals and permits.
- Environmental clearances and other permits required for setting up a pharmaceutical manufacturing unit.
- Environmental Impact Assessment (EIA) clearance to ensure that there are no potential environmental impacts of the project.
- No Objection Certificates (NOCs) from local authorities for different aspects like land use, water, and waste management.
If you are supposed to import some equipment and machinery, then you will have to get the Importer Exporter Code (IEC) from the Directorate General of Foreign Trade (DGFT).
You should comply with customs regulations and documentation requirements for importing machinery and equipment.
You should get a manufacturing or wholesale drug license from the state licensing authority.
You also need to obtain Product registration and marketing authorization from CDSCO for each product you produce.
Also read: How to Increase Sales in PCD Pharma?
