FOOD & DRUGS ADMINISTRATION


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:

  1. The Drugs & Cosmetic Act 1940 and Rules 1945
  2. The Pharmacy Act 1948
  3. The Drugs & Magic Remedies (Objectionable Advertisement) Act 1954
  4. The Cigarettes and other tobacco products (prohibition of advertisement and regulation of trade and commerce, production, supply & distribution) Amendment Act 2003
  5. Food Safety and Standards Act 2006, Rules 2011 and Regulations 2011
  6. The Drugs (Price Control) Order 2013
  7. The ND&PS (Regulation of Controlled Substances) Order 2013
  8. The ND&PS (Amendment) Act 2014 & Rules 2015 (RMI/Essential Narcotics)
  9. The Mizoram Poisons Possessions & Sales Rules 2015
  10. 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

 

  1. To ensure the availability of standard quality of drugs and cosmetics to the consumer and to ensure safety of blood transfusion.
  2. Availability of drugs at reasonable prices and to control hoarding and shortage of drugs in the state.
  3. To prevent objectionable and misleading advertisement in order to discourage self-medication and self-treatment.
  4. 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

E-mail id

1

Lalsawma Pachuau, JD, Controlling & Licensing  Authorty

DHS

9436152192

lalsawmapachuau2@gmail.com 

2

F.Lalliantluanga, DD

DHS

7005084957

lalliantluanga50@gmail.com

3

H.Vanlalnghaka,DD

DHS

9612351804

valadihmun@gmail.com

4

Lalchhandama,DD

DHS

8731915123

lalsandamadco@gmail.com

5

C.Ramdinmawii, AD

Champhai

9612178319

cramdinmawii7@yahoo.com

6

Laldinpuii, AD

DHS

9436147363

laldinpuii34@gmail.com

7

K.Lalngilneia, AD

Mamit

9436149156

mangilakhawlhring@gmail.com

8

Timothy Thanchungnunga, AD

Aizawl W

9436147360

hnialumtimothy742@gmail.com

9

R.Vanlalruata, AD

Aizawl E

943614370/

9862725384

vanlalruata90@gmail.com

10

R.Vanlalsiama, Ad

Lunglei

9436959040

siama_r@yahoo.co.in

11

Sarah Laldintluangi, AD

Serchhip

8413936387

sarahvch@gmail.com

12

B.Lalzamliana,DI

Aizawl W

8731993250

bawihtlungzama@gmail.com

13

Lalruatdika Varte,DI

Kolasib

8256993550

lalruatdikavarte14@gmail.com 

14

Judy Lalrengpuii,DI

DHS

9862367482

rokhumjudy@gmail.com 

15

Lalduhsangi,ADI

Mamit

9612208424

Duhsangihauhnar14@gmail.com 

16

Lianhmingthangi,ADI 

Siaha

6909890395

hmingralte23@gmail.com 

17

Zarzokimi,ADI

Champhai

9862331393

zarzokimi777@gmail.com 

18

Malsawmtluanga, ADI

Lunglei

9856255440

malavarte27@gmail.com 

19

Lianhmingthangi Ralte, ADI

Aizawl E

9612227021

desfrvr2018@gmail.com 

20

P.Laltlanzova, ADI

Lawngtlai

7085699197

tzpialtu3@gmail.com 

21

Caroline Rinzampuii, ADI

Serchhip

9612664586

carokholhring33@gmail.com 

22

Lorind Lalthannguri, ADI

Aizawl W

7085362884

lorindpachuau49@gmail.com


FOOD SAFETY PROGRAMME
(Food Safety and Standard 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

E-mail id

1

Secretary/Commissioner of H & F.W Deptt as Food Safety Commissioner

Secretariat

0389-2336641

comsecymiz@gamil.com

 

2

Lalsawma, Joint Director (Food & Drugs) as Deputy Food Safety Commissioner

DHS

9436152192

lalsawmapachuau2@gmail.com 

3

F.Lalliantluanga, Designated officer

DHS

7005084957

lalliantluanga50@gmail.com

4

H.Vanlalnghaka, Designated Officer

DHS

9612351804

valadihmun@gmail.com

5

Lalchhandama, Designated officer

DHS

8731915123

lalsandamadco@gmail.com

6

John Laldingliana
 Food Safety Officer

    FDA,DHS

6009315334

    

 

7

Lalrinkimi Pachuau, Food Safety Officer

FDA, DHS

9436375019

lrkpachuau@gmail.com 

 


 

MIZORAM PRICE MONITORING AND RESOURCE UNIT


Sl No

 

Name of Drugs Control Officers

 

Place of Posting

Mobile Number

E-mail id


1

PC Lalhmangaihzuali
Project Coordinator

FDA,DHS

 8258996678

    pclalhmangaihzuali@gmail.com

 


2

Lalawmsanga,           
Field Investigator


FDA, DHS

 
8974728576

 

awmapartheno83@gmail.com

 


3

MS Dawngliani Ralte,
DEO


FDA, DHS


7005618688

dongdongiralte264@gmail.com

 


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  

 

  1. 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.

 

  1. 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

  1. 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:-

ApplicationDocuments/information neededProcess FlowPaymentProcess 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 SBI30-60 Days


ApplicationDocuments/information neededProcess FlowPaymentProcess 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 SBI30-60 Days


 

ApplicationDocuments/information neededProcess FlowPaymentProcess 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 SBI30-60 Days

 

ApplicationDocuments/information neededProcess FlowPaymentProcess 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 SBI30-60 Days

 

ApplicationDocuments/information neededProcess FlowPaymentProcess 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 SBI30-60 Days


  • DETAILS & Procedure for Manufacturing License

            Click the following link below

            https://health.mizoram.gov.in/page/sugam-portal-for-manufacturing-license

          Details of Manufacturing License for Financial year 2022-2023


Note : 

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. Work Plan proposal under Memorandum of Understanding (MoU) for 2021 – 2022 for strengthening of food safety eco-system in the country was submitted to FSSAI. The work plan is approved and fund is due to be sanctioned in a short while.