Introduction to the Indian Pharmaceutical Industry
The pharmaceutical industry in India is slated to increase its value in the near future. From US$ 33 billion in 2017, it is expected to go up to US$ 55 billion by 2020. The domestic pharma industry grew from Rs 116,389 crore in 2017 to Rs 129,015 crore in 2018. That is a result of the rapidly rising pharmaceutical product exports of India.
Indian pharmaceutical firms supply over 80% of the antiretroviral drugs used to treat AIDS globally. India supplies 25% of all medicines used in the UK and 40% of generic drugs used in the United States.
An Opportunity to grow with the trend
It is natural for a business-minded person to throw the hat in the game while the industry is booming. Experts suggest that the pharmaceutical industry is thriving and poised for greater glories. Hence, it’s time to utilize the global and domestic surge in demand for pharma products. That can establish a viable enterprise in the long run. To open a pharmacy in India, chemist shop or a wholesale outlet, you will first need to fulfil a few procedural requirements.
Types of Pharmacy
Firstly, you will need to decide on the type of pharmacy you want to open. Is it a standalone pharmacy, a chain pharmacy, a hospital pharmacy, an online pharmacy or a township pharmacy. If you intend to open a standalone pharmacy, you can proceed with obtaining an LLP pharmacy registration in India. Else you can even register your business as a private limited company.
Eligibility for Pharmacy Registration in India
However, you need to be aware that in most states, a person needs to possess a university-recognized diploma or a degree in pharmacy. It will be helpful to obtain pharmacy registration in India such as Retail Drug License (RDL) from the State Drugs Standard Control Organization. The list of recognized and approved colleges is accessible through the Pharmacy Council of India website.
Prerequisites for Obtaining a Drug License
Along with qualifications, obtaining a drug license requires at least a shop area of 10 square meters. Space air conditioners and refrigerators will also be required to store drugs in the Chemist Shop.
Authorizations and Experience Required
If you are applying for a Wholesale Drug License (WDL), you will not need to possess any degree or diploma in pharmacy. But you will have to ensure that the sale of drugs will take place under the supervision of a registered pharmacist. A degree-holder with at least one year of experience in dealing with drugs can also conduct the same. In both retail pharmacy stores and wholesale pharmacy stores, drugs can only be sold by pharmacists who have been approved by the state’s Department of Drug Control.
Documentation & Forms Required
Aside from fulfilling these requirements, you will need to deposit a number of documents in order to obtain a Retail Drug Licence or a Wholesale Drug Licence. One can download these forms from the Central Drugs Standard Control Organization website. Even individual State Drugs Standard Control Organizations provide the same. Submit the mandatory forms with required documents to ensure the smooth functioning of pharmacy registration in India.
The application forms include Form 19 (for Retail Licence), Form 21 (for Wholesale Licence), Form 19B (for Retail Homeopathic license), Form 20C (for Wholesale Homeopathic License), Form 19C (for Retail and Wholesale license of Schedule X Drugs), and Form 19A (for Retail Restricted license).
Other documents required are pharmacist’s self-declaration, Cold Storage facilities installation proof, store layout, applicant identity proofs, proposed premise Rental/Lease agreement, list of company directors or proprietors, electricity bills, NOCs from residential societies, partnership deeds, and Documents of Trust Registration issued by the charity commissioner.
Online Pharmacy in India
The procedure for opening an online pharmacy in India is quite similar to opening a pharmacy in India. However, there are rules that have to be followed in both cases while they put more stress on online pharmacy law in India :
- No Sale without prescription
- No Sale of Schedule X drugs
- Final Packing in a tamper-proof cover under the personal supervision of registered Pharmacist of the pharmacy
- Valid Bill for Every sale
- Facilitate Medicine Recall in the case directed by the Government.
The IIPA is collaborating with the Central Government to update regulations by linking the Aadhaar Number with prescriptions to strengthen the online pharmacy law in India.
The first step for setting up an online pharmacy under Online Pharmacy Law in India is to buy a domain and hosting. Then associate an e-commerce portal with it. Later you can ensure the inclusion of payment options including cash on delivery and other preceding activities.
All the applicants have to pay a certain fee to acquire pharmacy registration in India. Post that the processing of your application begins for the grant of a Retail Drug Licence or a Wholesale Drugs Licence for opening a chemist shop. For instance, Maharashtra charges Rs. 3250 for Retail Chemist Shop Licenses, Rs. 3000 for Wholesale shop licenses, and an additional fee of Rs. 600 to allow the sale of Schedule X drugs.
Finally, before commencing a business, you will need to obtain a mandatory GST registration for your pharmacy registration in India. It is obtained from the state where your shop is located. Once this is done, you can purchase drugs from wholesale stores or from pharmaceuticals manufacturers. Post that you can begin selling them to buyers.
We are sure this information would be helpful for you. You can simply follow the above steps to obtain pharmacy registration in India and to start your chemist shop.