- Online National Drugs Licensing System (ONDLS)
- Manufacturing Licence Application (SUGAM)
- Online System for Medical Devices
- Drug Test Result Conform (Mizoram)
- Drugs Not of Standard Quality (CDSCO)
- Drugs Not of Standard Quality (Mizoram)
- CIRCULAR
- CANCELLATION
Drug Control in Mizoram has started its existence way back in 1986 where the first Drugs Inspector was recruited under Health & Family Welfare Department. With the gradual increase in number of regulatory staff in the later years the Government of Mizoram has reached to the decision to establish a better and meaningful drugs regulatory authorities by grabbing together the drugs control and food control under the name and style of Food & Drugs Administration Wing (FDA Wing). A gazette notification to this effect was issued vide No. A. 19019/09-HFW dated 26th September, 2012.
The main objective of FDA Wing is to protect and promote public health by assuring the safety, efficacy and quality of drugs, cosmetics, medical devices, and food & food products in Mizoram through the monitoring and enforcement of various regulations relating to food and drugs like:
- The Drugs & Cosmetic Act 1940 and Rules 1945
- The Pharmacy Act 1948
- The Drugs & Magic Remedies (Objectionable Advertisement) Act 1954
- The Cigarettes and other tobacco products (prohibition of advertisement and regulation of trade and commerce, production, supply & distribution) Amendment Act 2003
- Food Safety and Standards Act 2006, Rules 2011 and Regulations 2011
- The Drugs (Price Control) Order 2013
- The ND&PS (Regulation of Controlled Substances) Order 2013
- The ND&PS (Amendment) Act 2014 & Rules 2015 (RMI/Essential Narcotics)
- The Mizoram Poisons Possessions & Sales Rules 2015
- The Medical Devices Rules 2017
The FDA Wing also plays a crucial role in combatting misuse/abuse of prescription drugs having abusive potentials which has become a major concern of the society across the state among youngsters including school children. Also, the state being in the international border area has become an important gateway for illegal export and import of bulk drugs, pharmaceutical formulations, cosmetics and medical devices and food & food products and this has caused extra burden and bigger challenges in the enforcement sector.
AIMS AND OBJECTIVES
- To ensure the availability of standard quality of drugs and cosmetics to the consumer and to ensure safety of blood transfusion.
- Availability of drugs at reasonable prices and to control hoarding and shortage of drugs in the state.
- To prevent objectionable and misleading advertisement in order to discourage self-medication and self-treatment.
- To prevent misuse of abusive drugs.
The organizational set-up of Mizoram Drugs Control Administration comprises of the following Officers:
SL. NO. | NAME OF DRUGS CONTROL OFFICERS | PLACE OF POSTING | MOBILE NUMBER | EMAIL ID |
1 | F. Lalliantluanga, JD, Controlling & Licensing Authority | DHS | 7005084957 | |
2 | H. Vanlalnghaka, DD | DHS | 9612351804 | |
3 | C. Ramdinmawii, AD | Champhai | 9612178319 | |
4 | Laldinpuii, AD | DHS | 9436147363 | |
5 | K. Lalngilneia, AD | Mamit | 9436149156 | |
6 | Timothy Thanchungnunga, AD | Aizawl West | 9436147360 | |
7 | R. Vanlalruata, AD | Aizawl East | 9862725384 | |
8 | R. Vanlalsiama, AD | Lunglei | 9436959040 | |
9 | Sarah Laldintluangi, AD | Serchhip | 8413936387 | |
10 | B. Lalzamliana, DI | Aizawl West | 8731993250 | |
11 | Lalruatdika Varte, DI | Kolasib | 8256993550 | |
12 | Judy Lalrengpuii, DI | DHS | 9862367482 | |
13 | Lalduhsangi, ADI | Mamit | 9612208424 | |
14 | Lianhmingthangi, ADI | Siaha | 6909890395 | |
15 | Zarzokimi, ADI | Champhai | 9862331393 | |
16 | Malsawmtluanga, ADI | Lunglei | 9856255440 | |
17 | Lianhmingthangi Ralte, ADI | Aizawl East | 9612227021 | |
18 | P. Laltlanzova, ADI | Lawngtlai | 7085699197 | |
19 | Caroline Rinzampuii, ADI | Serchhip | 9612664586 | |
20 | Lorind Lalthannguri, ADI | Aizawl West | 7085362884 |
FOOD SAFETY PROGRAMME
(Food Safety and Standards Authority of India)
INTRODUCTION
Food Safety and Standards Act was enacted by the Parliament of India in its 56th year of Republic of India in the year 2006.This act is meant to consolidate the laws relating to food and also to establish a science based standards for article of food. It lays a direction, instruction and guidance with regards to manufacture, storage, distribution, sale & import and also to ensure availability of safe food and wholesome food for human consumption. Food Safety & Standards Cell of the Directorate of Health Services is responsible for the execution of the programme and works for the implementation of the Food Safety and Standards Act, 2006 and the Regulation, 2011.
OBJECTIVES/TARGET
Consumption of unsafe and unhygienic food can cause a number of avoidable diseases and can retard the development of the people. So,to ensure the availability of food that is hygienic and safe for consumption by human beings, educating the general public about their rights to food safety, checking and inspecting suspected food articles are the most important aims and objective of Food Safety & Standards Act, 2006. It provide provisions to prevent food adulteration and prohibit the sale of unsafe and sub-standards food and can also impose a severe punishment including imprisonment to those who does not comply and follow the provisions it.
FOOD SAFETY ENFORCEMENT
SL. NO. | NAME | PLACE OF POSTING | MOBILE NUMBER | EMAIL ID |
1 | Secretary/Commissioner of Health & Family Welfare Department as Food Safety Commissioner | Secretariat | 0389-2336641 | |
2 | F. Lalliantluanga, Joint Director (F&D) as Deputy Food Safety Commissioner | DHS | 7005084957 | |
3 | H. Vanlalnghaka, Designated Officer | DHS | 9612351804 | |
4 | Dr. L.C. Liana, Designated Officer | CMO Office, Lunglei | 9436147956 | |
5 | Dr. Lalnunziri, Designated Officer | CMO Office, Siaha | 9436149127 | |
6 | Dr. PC Lalhmingliana, Designated Officer | CMO Office, Champhai | 9233556978 | |
7 | Dr. Lalhlunpuii, Designated Officer | CMO Office, Mamit | 8787653590 | |
8 | Dr. RK Lalthlamuana, Designated Officer | CMO Office, Kolasib | 8974768597 | |
9 | Dr. David Zothansanga, Designated Officer | CMO Office, Lawngtlai | 9366441527 | |
10 | Dr. LP Malsawma, Designated Officer | CMO Office, Serchhip | 9612820165 | |
11 | John Laldingliana, Food Safety Officer | FDA, DHS | 6009315334 |
|
12 | Lalrinkimi Pachuau, Food Safety Officer | FDA, DHS | 9436375019 | |
13 | Mordekai Lalchhanhima, Food Safety Officer (Outsourced) | DHS | 9402508710 | |
14 | Rodawngkima, Food Safety Officer (Outsourced) | DHS | 8178894745 | |
15 | K. Zobiakfela, Food Safety Officer (Outsourced) | DHS | 7642925490 | |
16 | Esther Malsawmdawngliani, Food Safety Officer (Outsourced) | DHS | 9635872359 | |
17 | Dr. Nunhlupuii, Food Safety Officer (Outsourced) | DHS | 8794075894 | |
18 | Malsawmtluangi, Food Safety Officer (Outsourced) | DHS | 8974298440 | |
19 | Vanlalhmangaihi Colney, Food Safety Officer (Outsourced) | DHS | 8414935931 |
MIZORAM PRICE MONITORING AND RESOURCE UNIT
Sl. No. | Name of Drugs Control Officers | Place of Posting | Mobile Number | Email ID |
1 | PC Lalhmangaihzuali, Project Coordinator | FDA, DHS | 8258996678 | |
2 | Lalawmsanga, Field Investigator | FDA, DHS | 8974728576 | |
3 | MS Dawngliani Ralte, Data Entry Operator | FDA, DHS | 7005618688 |
ACHIEVEMENT OF FOOD & DRUGS ADMINISTRATION WING DURING 2023-24
DRUGS:
1. Drugs Store are regularly inspected to monitor their function and compliance to the Act & Rules to ensure only safe and quality drugs are dispensed to consumer
No. Of Drugs Store Inspection : 1115 Nos.
2. Drugs Licences operated in violation of the Drugs & Cosmetics act 1940 & Rules 1945 are either suspended for specific period or cancelled
No. Of Drugs Licence Suspended : 05 Nos.
No. of Drugs Licence Cancelled : 41 Nos.
3. Drugs Sample are drawn regularly for quality assurance and those found not of standard quality (NSQ) are recalled from market to safeguard public healthcare.
No. of sample drawn for analysis : 143 Nos.
No. of Not of Standard Quality drugs found : 05 Nos.
4. Cases are registered in the court of law against those dealing in drugs having no valid drug licence
No. of cases registered in the court of law : NIL
No. of conviction : Pending
5. Revenue collected: : Rs. 66,50,427/-
FOOD:
1. Under provision of FSS Act 2006 and Rules & Regulation 2011 any persons running/starting a food business services, He/She should obtain a Licence or Registration under the Act
- Registration: Food Business Operators whose annual turn over is less than 12 lakhs should obtain a Registration from the Registering Authority. Registration Fee is Rs.100/- per annum.
No. of Registration issued : 1933 Nos.
- Licence: FBO having an annual turnover more than 12 lakhs are bound to obtain Licence from the State Licensing Authority. Licence Fee is Rs.2000/- per annum.
No. of Licence issued : 62 Nos. (State)
2. Inspection of Food Dervice Establishment has been conducted many a time.
No. of Food Service Establishment Inspected : 50 Nos.
3. Collection/Lifting of Food sample: Any food items suspected by FSO are lifted/freeze by them and sent for analysis at Food Testing Laboratory.
No. of Food Sample lifted : 10 Nos.
4. Revenue collected: : Rs. 44,00,000/-
ACHIEVEMENT DURING 2022-23
DRUGS:
1. Drugs Store are regularly inspected to monitor their function and compliance to the Act & Rules to ensure only safe and quality drugs are dispensed to consumer
No. Of Drugs Store Inspection : 1146 Nos.
2. Drugs Licences operated in violation of the Drugs & Cosmetics act 1940 & Rules 1945 are either suspended for specific period or cancelled
No. Of Drugs Licence Suspended : 11 Nos.
No. of Drugs Licence Cancelled : 54 Nos.
3. Drugs Sample are drawn regularly for quality assurance and those found not of standard quality (NSQ) are recalled from market to safeguard public healthcare.
No. of sample drawn for analysis : 106 Nos.
No. of Not of Standard Quality drugs found : 11 Nos.
4. Cases are registered in the court of law against those dealing in drugs having no valid drug licence
No. of cases registered in the court of law : NIL
No. of conviction : Pending
- Revenue collected: : Rs. 20,25,050/-
FOOD:
1. Under provision of FSS Act 2006 and Rules & Regulation 2011 any persons running/starting a food business services, He/She should obtain a Licence or Registration under the Act
a. Registration: Food Business Operators whose annual turn over is less than 12 lakhs should obtain a Registration from the Registering Authority. Registration Fee is Rs.100/- per annum.
No. of Registration issued : 1753 Nos.
b. Licence: FBO having an annual turnover more than 12 lakhs are bound to obtain Licence from the State Licensing Authority. Licence Fee is Rs.2000/- per annum.
No. of Licence issued : 74 Nos. (State)
Nos. (Central)
c. Inspection of Food Device Establishment has been conducted many a time.
No. of Food Service Establishment Inspected : 85 Nos.
d. Collection/Lifting of Food sample: Any food items suspected by FSO are lifted/freeze by them and sent for analysis at Food Testing Laboratory
No. of Food Sample lifted : 10 Nos.
Revenue collected: : Rs. 35,000,00/-
Citizens's Charter
STANDARD OPERATING PROCEDURE:-
| Application | Documents/information needed | Process Flow | Payment | Process Duration |
| Application for General Retail Licence (Form19) | 1)Application Form 19 2)Passport Photo of applicant (6 copies ) 3)Passport Photo of Pharmacist (6 copies) 4)Plan layout of premises 5)Supervision Agreement (Licensee and Pharmacist) 6)Ownership Certificate of the premises 7)Rental Agreement 8)Residential Certificate from Local Council/VC 9)Educational Qualification Certificate 10)Aadhaar/Voter ID | 1)Application Form to be obtained from District Office 2)Submission of Application Form & necessary documents to District Office 3) Spot Verification by the concerned Regulators from District Office 4)Submission of Application & necessary documents, Challan & Verification Report to State Licensing Authority. 5) Approval/Rejection of Application. 6) Issuance of Licence (Form 20&21) | Rs.3000/- through challan at SBI | 30-60 Days |
| Application | Documents/information needed | Process Flow | Payment | Process Duration |
| Application for Restricted Retail Licence (Form19A) | 1)Application Form 19 2)Passport Photo of applicant ( 6 copies ) 3)Plan layout of premises 4)Ownership Certificate of the premises 5)Rental Agreement 6)Residential Certificate from Local Council/VC 7)Educational Qualification Certificate 8)Aadhaar/Voter ID | 1)Application Form to be obtained from District Office 2)Submission of Application Form & necessary documents to District Office 3) Spot Verification by the concerned Regulators from District Office 4)Submission of Application & necessary documents, Challan & Verification Report to State Licensing Authority. 5) Approval/Rejection of Application. 6) Issuance of Licence (Form 20A&21A) | Rs.1000/- through challan at SBI | 30-60 Days |
| Application | Documents/information needed | Process Flow | Payment | Process Duration |
| Application for Wholesale Licence (Form19) | 1)Application Form 19 2)Passport Photo of applicant ( 6 copies ) 3)Passport Photo of Pharmacist (6 copies) 4)Plan layout of premises 5)Supervision Agreement (Licensee and Pharmacist) 6)Ownership Certificate of the premises 7)Rental Agreement 8)Residential Certificate from Local Council/VC 9)Educational Qualification Certificate 10)Aadhaar/Voter ID | 1)Application Form to be obtained from District Office 2)Submission of Application Form & necessary documents to District Office 3) Spot Verification by the concerned Regulators from District Office 4)Submission of Application & necessary documents, Challan & Verification Report to State Licensing Authority. 5) Approval/Rejection of Application. 6) Issuance of Licence (Form 20B&21B) | Rs.3000/- through challan at SBI | 30-60 Days |
| Application | Documents/information needed | Process Flow | Payment | Process Duration |
| Application for Licence to sale drugs by wholesale or distribute from motor vehicle (Form 19AA) | 1)Application Form 19AA 2)Original copy of wholesale licence in 20B&21B 3) Transport Vehicle Complete Document 4)Passport Photo of applicant ( 6 copies ) 5)Ownership Certificate of the premises 6)Rental Agreement | 1)Application Form to be obtained from District Office 2)Submission of Application Form & necessary documents to District Office 3) Spot Verification by the concerned Regulators from District Office 4)Submission of Application & necessary documents, Challan & Verification Report to State Licensing Authority. 5) Approval/Rejection of Application. 6) Issuance of Licence (Form 20BB&21BB) | Rs.500/- through challan at SBI | 30-60 Days |
| Application | Documents/information needed | Process Flow | Payment | Process Duration |
| Application for Homoeopathic Retail Licence (Form 19B) | 1)Application Form 19B 2)Passport Photo of applicant ( 6 copies ) 3)Passport Photo of Pharmacist (6 copies) 4)Plan layout of premises 5)Supervision Agreement (Licensee and Pharmacist) 6)Ownership Certificate of the premises 7)Rental Agreement 8)Residential Certificate from Local Council/VC 9)Educational Qualification Certificate 10)Aadhaar/Voter ID | 1)Application Form to be obtained from District Office 2)Submission of Application Form & necessary documents to District Office 3) Spot Verification by the concerned Regulators from District Office 4)Submission of Application & necessary documents, Challan & Verification Report to State Licensing Authority. 5) Approval/Rejection of Application. 6) Issuance of Licence (Form 20C) | Rs.250/- through challan at SBI | 30-60 Days |
Note :
- Govt. Of Mizoram had given permission for engagement of empanelled consultancy firm for construction of State Drug Testing Laboratory amounting to Rs 250 lacs as funded by Central Government and work had started from December 2019. Inaugurated on 18th October 2022.
- Mizoram Drugs Price Monitoring Research Unit been set up on September 2020. Since its inception 29 Nos. of violations ( particular brand of drugs sold above MRP) had been detected and reported tor NPPA.
- Relating to Covid-19 FDA had work tirelessly to maintain the standard of Hand Sanitizer and in this regard, 6 brand of not of standard quality hand sanitizer were seized from the market.Vit C tablet (mfg Saratra Healthcare, Dehradu) had been found NSQ and recalled from market. FDA had been very vigil to check black marketing of covid related medicine (eg Ramdesivir, tocilizumab etc).
- Food Safety on Wheels: A Mobile Food Testing Laboratory called Food Safety on Wheels was received from Food Safety and Standard Authority of India, MoHFW. This is being utilised on the roads. The vehicle is equipped with various food testing equipments for testing aflotoxin, microbiological, milk, oil etc.
