Central Information Commission
Seema Sinha vs Central Drugs Standard Control ... on 21 February, 2024
Author: Heeralal Samariya
Bench: Heeralal Samariya
के न्द्रीयसूचनाआयोग
Central Information Commission
बाबागंगनाथमागग, मुननरका
Baba Gangnath Marg, Munirka
नईदिल्ली, New Delhi - 110067
नितीय अपील संख्या / Second Appeal No. CIC/CDSHQ/A/2023/634532
Ms. Seema Sinha ... अपीलकताग/Appellant
VERSUS/बनाम
PIO, ...प्रनतवािीगण /Respondent
Central Drugs Standard Control Organization,
HQ, New Delhi
Date of Hearing : 21.02.2024
Date of Decision : 21.02.2024
Chief Information Commissioner : Shri Heeralal Samariya
Relevant facts emerging from appeal:
RTI application filed on : 25.05.2023
PIO replied on : 16.06.2023
First Appeal filed on : 19.06.2023
First Appellate Order on : 07.07.2023
2 Appeal/complaint received on
nd : Nil
Information soughtand background of the case:
The Appellant filed an RTI application dated 25.05.2023 seeking information on following points:-
"A-In appendix VI of schedule Y of drugs and cosmetics act mentioned that the fixed dose combinations refer to product containing one or more active ingredients used for a particular indication(s) B-according to rule 122A-1228-122D and 122DA, necessary information/data are for approval to manufacturers a new drug or fixed those combinations are 1- name of the drug, 2-doses form, 3-composition of the formulation, 4-taste specifications for active ingredients and inactive ingredients, 5-pharma co logical classification, 6-indication for which proposed to be used, 7-manufacturer of the raw material, 8-paytent status of the drug.
C-All the manufacturer of vitamins and mineral product are listed in RTI request no. CDSCO/R/E/23/00127 AND CDSCO/R/E/23/00142 are sold as nutritional supplements or for vitamins and minerals deficiency state but Page 1 of 4 your office latter no. file no. Z-28020/125/2023-DC mentioned that there is no definition of nutritional supplements prescribed under the drug and cosmetic act 1940 and Rules made there under.
D-in view of all the above mentioned point CPIO has not provided proper information only provide misleading and ambiguous information, primarily my request is to provide all the approval letter form-46 of the product listed in my above mentioned RTI requests.
E- What are the legal liabilities of CDSCO and drug authorities in view of violations of rules and regulations for misleading information and exaggerated claims because some of product listed in above mentioned RTI request mentioned, drug description in QR code form as a nutritional supplement and for various vitamins and minerals deficiency state, clearly it is violations of rules and regulations of drug and cosmetic act 1940 in such case which authority is liable for curbing this type of discrepancy."
The CPIO/Central Drugs Standard Control Organization vide letter dated 16.06.2023 replied as under:-
"Point no. A to E: This office functions under the provisions of Drugs and Cosmetics Act 1940 and Rules made thereunder.
Further, Clarification/interpretation does not come section 2(f) under the RTI Act 2005."
Dissatisfied with the response received from the CPIO, the Appellant filed a First Appeal dated 19.06.2023. The FAA and Jt Drugs Controller, Central Drugs Standard Control Organization vide order dated 07.07.2023 stated as under:-
"As per Drugs & Cosmetics Act & Rule the licences to manufacture for sales or sales and distribution of Drugs are granted by the State Licensing authorities appointed by the respective State Government. However, for new drugs including FDCs falls under definition of new drug, permission from CDSCO is required before obtaining licenses from State Licensing Authority. (Drugs and Cosmetics Act 1940 & Rule made thereunder are available on CDSCO website i.e. www.cdsco.gov.in). You are also requested to refer the CDSCO website i.e. www.cdsco.gov.in regarding status of various FDCs."
Aggrieved and dissatisfied, the Appellant approached the Commission with the instant Second Appeal.
Facts emerging in Course of Hearing:
A written submission has been received from the CPIO, Central Drugs Standard Control Organization vide letter dated 14.02.2024 the relevant extracts of which are as under:Page 2 of 4
Further applicant has refer RTI request no. CDSCO/R/E/23/00127 and CDSCO/R/E/23/00142 under First RTI filed vide RTI application registration no.: CDSCO/R/E/23/00205 in which applicant ask "Please provide the all approval letter under drug and cosmetic act 1940 for nutritional supplements and products for various vitamins and minerals deficiency state that is issued by you for drug listed below 1-polybion CZS tablet 2-Nurokind Gold RF 3-orofer XT 4-Cheri XT 5-Shelcal XT 6-Neurobion forte 7- Surbex XT 8-Nurokind forte Z 9-RICHAR CR 100 10-Macraberin forte" and "1-1n view of your letter no file no Z- 28020/125/2023-/DC dated12/04/23 , please give your opinion about following products under section 2(f) of rti act 2005,how can you approve these product as nutritional supplements or for vitamins and minerals deficiency state please provide approval letter of all following products which has issued by you 1- supradyn daily 2-Livogen capsule 3- Aristo V Total tablet 4-fourts B 5-B-29 6-Zincofer nurture 7-mecofol plus NF 8-Nurokind OD 9-nurokind D3 10- Ferium XT 11-Z&B soflets 12-surbex Gold 13- NVM-M12 OD Tablets".
In this regard it is to mention that the CPIO has already provided the available requisite information to the applicant as "Manufacture, sale and distribution of drugs are regulated under Drugs & Cosmetic Act, 1940 & Rules 1945 thereunder. There is no provision under Drugs & Cosmetic Act & Rules to approve nutritional supplement. CDSCO deals with quality, safety and efficacy of drugs and approves the drugs in proper name only. Further no composition/strength of the products are mentioned in your application"
In view of above, the CPIO has always acted reasonably & diligently with bonafide intent and do not have any intention to hide the information as sought by the applicant.
Facts emerging in Course of Hearing:
Appellant: Absent Respondent: 1. Shri Ashok Kumar Yadav, CPIO and ADC (I);
2. Shri Vijay K Chandrakar DDC (I);
3. Shri R Venkateshwarlu, AD (I) The Appellant remained absent during the hearing despite prior intimation.
Shri Ashok Kumar Yadav reiterated the replies provided to the Appellant and stated that although the queries of the Appellant were clarificatory in nature yet information as per available record was provided by them. Decision:
Keeping in view the facts of the case and the submissions made by the Respondent, the Commission is of the view that an appropriate response as per Page 3 of 4 the provisions of the RTI Act, 2005 has been provided. Hence, no further intervention of the Commission is required in the instant matter.
With the above observation, the instant Second Appeal stands disposed off accordingly.
Heeralal Samariya (हीरालाल सामररया) Chief Information Commissioner (मुख्य सूचना आयुक्त) Authenticated true copy (अनिप्रमानणत सत्यानपत प्रनत) S. K. Chitkara (एस. के . नचटकारा) Dy. Registrar (उप-पंजीयक) 011-26186535 Page 4 of 4