1. RULES FOR CHEMIST:
Presented By-Dr. Apoorva Mishra, Dr. Deepak Baid, Dr. Deepak Tanwar, Dr. Mahesh Suman, Dr. Prachi Garg, Dr. Samuel N David
Reviewed By- Dr Vijay Agarwal, Dr Lallu Joseph, Dr Narayan Pendse, Dr CM Bhagat

2. LIST OF LICENCES

3. LIST OF LICENCES

4. GENERAL RULES
1.) Required area of the proposed business premises 108 Sq. Ft. (Carpet Area)
2.) Required ceiling height 8‘2" minimum.
3.) The premises shall be brick built, plastered floor cemented with mac. roofing.
4.) The proposed premises should be completely separated with completely separate and identical entrance (No residential common passage will be allowed)

5. GENERAL RULES
5.) House owner of the proposed premises should sign himself in full, in the rent bill.
6.) Address of the firm must be same as In House Tax Receipt In all related papers.
7.) Items No: 9,10 & 11 are to be verified by the PRC. / Head Assistant of FDA office before submitting the application.

6. LICENCES 1)Application in Form No: 19.
FOLLOWING PAPERS ARE REQUIRED FOR ALLOPATHIC DRUGS IN FORM 208 & 21 B (AFTER QUALIFYING THE PRELIMINARY INTERVIEW)
1)Application in Form No: 19.
2) Additional information form (With Competent Person's present photograph)
Pharmacist presence mandatory for dispensing.
3)T.R. Challan No: 7 showing Licence fees of Rs. 3000/(For Biological & Non Biological Licences) deposited at R.B.l. / S.B.l. Main branch. .

7. LICENCES
4) XEROX COPY OF HOUSE RENT BILL (In case of rented shop premises), with full signature of House owner.
5) Xerox copy of House Tax Receipt (Issued by local Municipality / Government Tax
Receipt issued by B.L.R.O.) in case of Panchayat area
6) Xerox copy of Purchase record of Refrigerator
7) Partnership/ LLP deed (copy) in case of partnership firm (if registered no other papers are required)
8) Sketch plan with actual dimensions, surroundings .
9) An affidavit as stating that applicant will be liable for any false. misleading

8. STATUTORY LICENCE/ REQ
*FDA
*Shop n Establishment licence
*PAN card
*GST

9. STOCKING OF MEDICINE
As per provisions of Drugs and Cosmetic: Act and Rules. item 5 of Schedule K of the Drugs and Cosmetics rules
Exempts the Registered Medical Practitioners from taking out drug licenses for stocking and selling drugs to their own patients, provided
the practitioner:
i) Does not maintain an open shop in the hospital premises
ii) Does not sell drugs across a counter.
iii)Does not engage in the importation, manufacture distribution or sale of drugs in the provision of chapter 01 of the Act and the rules thereunder.

10. QUALITY MANUALS *Room temperature record : 24 degrees
* To check fridge temperature and maintain record daily.
* Maintain stock as per protocol for medicines : LASA / HIGH RISK DRUGS

11. ADDITIONAL RULES
1) Hospitals cannot insist in purchase of medicines from hospital chemist.
2) Even cut strips of medicine need to be dispensed by chemist if asked for.
3) Online sale of medicine is prohibited without prescription.

12. DRUGS REQ LICENCE/ RECORDS
MTP Pills
Narcotic drugs
And schedule X drugs
( Tamiflu has now been removed from schedule X)
For these: prescription in triplicate needs to be given on the doctor's letter head with signature and stamp.

13. NARCOTICS ACT: TITBIT 1)Its under the Excise and customs department.
2) But whenever the Drug is ceased , Its kept under the collector.
The collector is also responsible for attachment of property in case of default of fine/ absconding.

14. THANK YOU