IN THE HIGH COURT AT CALCUTTA

(Constitutional Writ Jurisdiction)

APPELLATE SIDE

Present:

The Hon’ble Justice Krishna Rao

W.P.A. No. 20748 of 2026

ICHOR Biologics Private Limited

Vs.

The State of West Bengal & Ors.

Mr. Jaydip Kar, Sr. Adv.

Mr. Suman Kumar Dutt, Sr. Adv.

Mr. Soumya Majumdar, Sr. Adv.

Mr. Paritosh Sinha

Mr. Amitava Mitra

Ms. Sumita Shaw

Mr. Sakabda Roy

Mr. Naman Agarwal

Ms. Shrestha Dutta

Ms. Anusuya Thatoi

....For the petitioner.

Mr. Surajit Nath Mitra, Ld. A.G.

Mr. Billwadal Bhattacharyya, Ld. A.A.G.

Mr. Shivshankar Banerjee

Mr. Srijib Chakraborty

Mr. Aditya Mondal

Mr. Shiv Shankar Banerjee

2

Mr. Jatinder Singh Dhatt

….For the respondents.

Hearing Concluded On : 21.09.2026

Judgment Delivered On : 30.09.2026

Judgment Uploaded On : 30.09.2026

Krishna Rao, J.:

1. The petitioner has filed the present writ petition challenging the

communication dated 30

th July, 2026 wherein and where under the

technical bid of the petitioner was rejected. On 19

th May, 2026, the

respondents have published a Notice Inviting e-Tender for collecting

excess/surplus available screened of Fresh Frozen Plasma (FFP) from

different BCSU (Blood Component Separation Unit) attached to the

State Government Blood Centres across the West Bengal Initially for a

period of 1 (one) year and may be extended for a further period of 1

(one) year under same terms & conditions subject to satisfactory

performance.

2. The petitioner has participated in the said tender process. On 22

nd

June, 2026, the Tender Committee opened the bids for technical

evaluation in presence of the representative of the petitioner and other

bidders. On 1

st July, 2026, the tendering authority requested the

petitioner to provide attested copy of the license for manufacturing

blood products, Income Tax Returns for the year 2024-25 and the PAN

of the petitioner. On 3

rd July, 2026, the petitioner has submitted the

required documents to the tendering authority.

3

3. On 24

th July, 2026, the technical bid of the petitioner was rejected

with the remark “Not Qualified Technically”. The petitioner has made

representation on 28

th July, 2026, to the respondents requesting the

respondents the reasons for the technical disqualification and also

requested for opportunity of personal hearing before the Technical Bid

Evaluation Committee. In spite of several requests made by the

petitioner, the respondent authorities have neither informed the

petitioner about the reasons for rejection of the technical bid of the

petitioner nor any opportunity of hearing was provided to the

petitioner, the petitioner has filed the present writ petition.

4. Mr. Jaydip Kar, Learned Senior Advocate, representing the petitioner

submits that the license to manufacture and store blood products for

sale or distribution was issued to the petitioner by the competent

authority on 1

st April, 2021 which was valid up to 31

st March, 2026.

On 10

th November, 2025, the petitioner has submitted an application

to the Director, Drugs Control Administration for renewal of

Manufacturing license of the petitioner under Form-28-E.

5. On 24

th

April, 2026, the Drugs Control Administration, Government of

Telangana, renewed the license of the petitioner with effect from 1

st

April, 2026 to 31

st

March, 2031 by issuing License Retention

Certificate. On 22

nd

June, 2026, the Licensing Authority has issued

Certificate of renewal of license to Manufacture of Blood Products

under FORM26-I. The petitioner has participated in the tender

process with the said certificate of renewal issued under Form26-I.

4

6. The respondent authorities have filed report and in the said report,

the reason for disqualification of the petitioner in the technical bid

was disclosed. As per report filed by the respondent authorities, the

manufacturing license which the petitioner has submitted along with

other tender documents, the manufacturing license is not duly

endorsed by the Drug Controller General of India (hereinafter referred

to as “DCGI”) which is an essential requirement.

7. Mr. Kar submits that as per Rule 122H of the Drugs Rules, 1945,

once the original license is renewed either in Form 26-G or in Form

26-I shall be valid for a period of five years on and from the date on

which it is granted or renewed unless it is suspended or cancelled. He

submits that as on date of opening of technical bid of the petitioner,

the petitioner had the valid license but the respondent authorities

have disqualified the petitioner in the technical bid only on the ground

that the license of the petitioner is not endorsed by the Drug

Controller General of India which is not the requirement.

8. Mr. Kar submits that the Licensing Authority by a letter dated 22

nd

June, 2026, forwarded the approval for the Renewal License in Form

26-I (Form 28-E) in triplicate with endorsement of State Licensing

Authority for approval of Central Licensing Approving Authority and

requested the Drug Controller General of India to return the same in

duplicate after approval for taking necessary action.

5

9. Mr. Kar submits that Licensing authority defined under Rule 21(b) of

the Drugs Rules, 1945 and the said Licensing Authority has granted

license to the petitioner which is valid from 1

st April, 2026 to 31

st

March, 2031 but the respondents have not considered the said license

of the petitioner and arbitrarily rejected the technical bid of the

petitioner.

10. Mr. Kar relied upon Rule 122F of the Drugs Rules, 1945 and submits

in 2

nd

proviso of the said Rule provides that the licensee holding a

license in Form 28-C, Form-28-E or Form 28-F as the case may be, for

operation of [Blood Centre]/ processing of whole human blood for

components/ manufacture of blood products/collection, processing,

testing, storage, banking and release of umbilical cord blood stem

cells shall apply for grant of license under sub-rule (1) before the

expiry of the said license on Form 27-C, Form 27-E or Form 27-F as

the case may be, and he shall continue to operate the same till the

orders on his application are communicated to him. He submits that

the licensing authority has renewed the license of the petitioner with

effect from 1

st

April, 2026 and is valid till 31

st

March, 2026 but the

respondent authorities have rejected the technical bid of the

petitioner.

11. Mr. Kar further relied upon Rule 122-I and submits that before

renewal of the license of the petitioner, the licensing authority

inspected the premises of the petitioner, verified appliances/

equipments, test facilities and professional qualification of the expert

6

staffs and other technical staffs employed by the petitioner and

thereafter renewed the license of the petitioner but the respondent

authorities have not relied upon the license issued by the competent

authority upon completion of all formalities.

12. Learned Advocate General appearing for the State submits that as per

the Eligibility Criteria of the tender notice, any firm/ company should

have a valid license for manufacturing plasma derived products. The

firm should furnish attested photocopy of License for manufacturing

plasma derived products approved by the Licensing Authority. He

submits that the petitioner has submitted license issued by the

Licensing Authority but is not approved by the Central License

Approving Authority. He submits that it is admitted by the petitioner

that after renewal of license of the petitioner by the Licensing

Authority, the same was forwarded to Drug Controller General, India

for approval but till date the Central License Approving Authority has

not approved the license of the petitioner.

13. Learned Advocate General submits that the previous license was

issued and relied by the petitioner which was issued on 20

th

May,

2021 and was valid from 1

st

April, 2021 to 31

st

March, 2026 in the

said license, other than the signature and seal of the Licensing

Authority, there is an endorsement by the Central License Approving

Authority but in the present tender process, the license which the

petitioner has relied upon, there is no endorsement of the Central

license Approving Authority.

7

14. Learned Advocate General submits that the petitioner has submitted

certificate issued by the Licensing Authority dated 22

nd June, 2026,

without any seal and signature of the Central License Approving

Authority. The Licensing Authority by a letter dated 22

nd June, 2026,

forwarded the approval of Renewal License in Form 26-I in triplicate

with endorsement of the State Licensing Authority for approval of the

Central License Approving Authority with the request to return the

same in duplicate after approval for taking necessary action at the end

of the Licensing Authority which itself proves that the license which

the petitioner has relied upon is not approved by the Central License

Approving Authority. He submits that at this stage on the basis of the

Renewal License issued by the Licensing Authority without approval of

the Central License Approving Authority, the tender is accepted and

work order, if any, is issued to the petitioner and if the Central

License Approving Authority later not approved the renewed license

issued by the Licensing Authority, the tender process initiated by the

respondent authorities would become redundant.

15. The issue involved in the present writ petition whether without the

approval of the Central License Approving Authority of the license

issued by the Licensing Authority, the respondents can accept the

said license issued by the Licensing Authority for allowing the

petitioner to participate in the financial bid.

16. Clause 4(a) of the eligibility criteria of the tender documents reads as

follows:

8

“4. (a) Any Firm/Company should have a

valid license for manufacturing plasma derived

products. The firm should furnish attested

photocopy of License for manufacturing plasma

derived products approved by the Licensing

authority.”

17. The petitioner had the License to Manufacture and Store Blood

Products for Sale or Distribution issued by the Licensing Authority

duly approved by the Central License Approving Authority dated 20

th

May, 2021 and was valid from 1

st

April, 2021 to 31

st

March, 2026. On

10

th

November, 2025, the petitioner has applied for renewal of the

license of the petitioner before the Drugs Control Authority. The

Licensing Authority renewed the license of the petitioner under FORM

26-I dated 22

nd June, 2026 which is as follows:

“FORM 26-I

(See Rule 122-I)

Certificate of renewal of license to manufacturing of Blood Products

1. Certified that License no. 02/RR/AP/2013/BP/CC on dated 01/04/2021

in Form28-E to M/s Ichor Biologics Pvt. Ltd., situated at Survey No. 222P.

Turkapally (V), Shameerpet (M), Medchal Malkajgiri District, Telengana-

500078, India is hereby renewed with License No.

02/RR/AP/2013/BP/R with effective from 01/04/2026 TO 31/03/2031.

2. Name (s) of the items : Products List Enclosed with the License.

3. Name /(s) of competent Technical Staff

(a) Responsible for Manufacturing

1. Mr. Manish Aditya. G.B. Pharmacy as manufacturing Chemist

(b) Responsible for Testing

2. Mrs. B. Ramya Sri, M.Sc. Biochemistry as Analytical Chemist

9

Dated : 22.06.2026

SIGNATURE

NAME AND DESGINATION

LICENSING AUTHROTITY.

CENTRAL LICENSE APPROVING AUTHROTY//.”

18. Admittedly, the renewed license relied by the petitioner under FORM

26-I is issued by the Licensing authority is not approved by the

Central License Approving Authority and is pending before the

Approving Authority. While providing the renewed License under

FORM 26-I to the petitioner, the Licensing Authority has forwarded

the same to the Drugs Controller General (I) for approval of the

Renewal License in FORM 26-I.

19. Rule 68 of the Drugs Rules, 1945, provides for Grant of License by the

Central License Approving Authority which reads as follows:

“68-A. Grant or Renewal of Licences by

the Central Licence Approving Authority.— (1)

Notwithstanding anything contained in this Part, on

and from the commencement of the Drugs and

Cosmetics (9

th Amendment) Rules, 1992, a licence

for the manufacture for sale or distribution of drugs

as specified from time to time by the Central

Government by notification in the Official Gazette,

for the purpose of this rule, shall be granted [***],

by the Central Licence Approving Authority

(appointed by the Central Government):]

PROVIDED that the application for the grant

[***] of such licence shall be made to the Licensing

Authority.

(2) On receipt of the application for grant [***]

of a licence, the licensing authority shall,-

10

(i) verify the statement made in the

application form;

(ii) cause the manufacturing and testing

establishment to be inspected in accordance

with the provisions of rule 79; and

[***]

(3) If the licensing authority is satisfied that

the applicant is in a position to fulfil the

requirements laid down as in these Rules, he shall

prepare a report to that effect and forward it along

with the application [and the licence (in triplicate) to

be granted [***], duly completed] to the Central

Licence Approving Authority:

PROVIDED that if the licensing authority is of

the opinion that the applicant is not in a position to

fulfil the requirements laid down in these Rules, he

may, by order, for reasons to be recorded in

writing, refuse to grant [***] the licence, as the case

may be.

(4) If on receipt of the application and the

report of the licensing authority referred to in sub-

rule (3) or after taking such measures including

inspection of the premises by the Inspector,

appointed by the Central Government under section

21 of the Act, with or without an expert in the

concerned field if deemed necessary, the Central

Licence Approving Authority, is satisfied that the

applicant is in a position to fulfil the requirements

laid down in these Rules, he may grant or renew

the licence, as the case may be:

PROVIDED that if the Central Licence

Approving Authority is of the opinion that the

application is not in a position to fulfil the

requirements laid down in these rules, he may,

notwithstanding the report to the licensing

authority, by order, for reasons to be recorded in

writing, reject the application for grant [***] of

licence, as the case may be.]”

11

As per the Rule 68A, the Central Licence Approving Authority is

the decision taking authority for grant or rejects the application for

grant of licence.

20. Rule 81 provides for Procedure of Licensing Authority. As per the said

provision also if the Licensing Authority or Central Licence Approving

Authority after receipt of report of Inspector, they may cause further

enquiry, if any, and is satisfied that the requirements of the Rule is

complied with and the condition of the licence and the rules will be

observed, he shall issue licence. If the Licensing Authority or Central

Licence Approving Authority is not satisfied he shall reject the

application and shall inform the applicant of the reasons for such

rejection.

21. Rule 122F of the Drugs Rules, 1945 reads as follows:

“122F. Form of application for licence for

operation of [Blood Centre]/ processing of whole

human blood for components/manufacture of blood

products for sale or distribution [collection,

processing, testing, storage, banking and release of

umbilical cord blood stem cells.]

(1) Application for the grant and/or renewal of

licence for the operation of a [Blood Centre]/

processing of Human Blood for components/

manufacture of Blood Products [collection,

processing, testing, storage, banking and release of

umbilical cord blood stem cells] shall be made to

the Licensing Authority appointed under Part VII in

[Form 27-C [Form 27-E or Form 27-F], as the case

may be], and shall be accompanied by [licence fee

of rupees six thousand and an inspection fee of

rupees one thousand and five hundred for every

inspection thereof or for the purpose of renewal of

licence]:

12

PROVIDED that if the applicant applies for

renewal of licence after its expiry but within six

months of such expiry the fee payable for the

renewal of the licence [shall be rupees six thousand

and inspection fee of rupees one thousand and five

hundred plus an additional fee at the rate of

rupees one thousand per month or a part thereof in

addition to the inspection fee:]

[PROVIDED FURTHER that a licensee holding

a license in Form 28-C, Form 28-E or Form 28- F as

the case may be, for operation of [Blood Centre/

processing of whole human blood for components /

manufacture of blood products/ collection,

processing testing storage, banking and release of

umbilical cord blood stem cells shall apply for grant

of license under sub Rule (1) before the expiry of

the said license in Form 27-C, Form 27-E or Form

27-F as the case may be and he shall continue to

operate the same till the orders on his application

are communicated to him.]

[***]

(2) A fee of [rupees one thousand] shall be

paid for a duplicate copy of a licence issued under

this rule, if the original is defaced, damaged or lost.

(3) Application by a licensee to manufacture

additional drugs listed in the application shall be

accompanied by a fee of [rupees three hundred] for

each drug listed in the application.

(4) On receipt of the application for the grant or

renewal of such licence, the Licensing Authority

shall,–

(i) verify the statements made in the

application form;

(ii) cause the manufacturing and testing

establishment to be inspected in accordance

with the provision of rule 122-I; and

(iii) in case the application is for renewal

of licence, call for information of past

performance of the licensee.

(5) If the Licensing Authority is satisfied that

the applicant is in a position to fulfil the

13

requirements laid down in the rules, he shall

prepare a report to that effect and forward it [along

with the application and the licence (in triplicate) to

be granted or renewed, duly completed] to the

Central Licence Approving Authority:

PROVIDED that if the Licensing Authority is of

the opinion that the applicant is not in a position to

fulfil the requirements laid down in these rules, he

may, by order, for reasons to be recorded in

writing, refuse to grant or renew the licence, as the

case may be.

(6) If, on receipt of the application and report of

the Licensing Authority referred to in sub-rule [(5)]

and after taking such measures including

inspection of the premises by the Inspector,

appointed by the Central Government under section

21 of the Act, and/or along with the expert in the

field concerned if deemed necessary, the Central

Licence Approving Authority is satisfied that the

applicant is in a position to fulfil the requirements

laid down in these rules, he may grant or renew

the license as the case may be:

PROVIDED that if the Central Licence

Approving Authority is of the opinion that the

applicant is not in a position to fulfil the

requirements laid down in these rules he may,

notwithstanding the report of the Licensing

Authority, by order for reasons to be recorded in

writing reject the application for grant or renewal of

the licence, as the case may be and shall supply

the applicant with a copy of the inspection report.”

In this Rule also if the Licensing Authority is satisfied that the

applicant is in a position to fulfil the requirements laid down in the

Rules, he will prepare report and forwarded the application and the

licence to be granted or renewed to the Central Licence Approving

Authority. The Central Licence Approving Authority is satisfied that

the applicant is in a position to fulfill the requirements laid down in

the rules, he may grant or renew the licence. As per proviso, if Central

14

Licence Approving Authority is of the opinion that the applicant is not

in a position to fulfil the requirements laid down in rules he may,

notwithstanding the report of the Licensing Authority reject the

application for grant or renewal of licence as the case may be.

22. In the present case, the licence issued to the petitioner to

manufacture and store blood products for sale or distribution dated

20

th

May, 2021 was effective from 1

st

April, 2021 to 31

st

March, 2026.

On 10

th

November, 2025, the petitioner has applied before the Drugs

Control Authority for renewal of licence. The Licensing Authority by a

letter dated 22

nd

June, 2026, forwarded the Renewal Licence in Form

26-I (Form 28-E) in triplicate with endorsement of the State Licensing

Authority for the approval of the Central Licence Approving Authority.

The copy of Renewal Licence in Form 26-I was also provided to the

petitioner. Till date, the Central Licence Approving Authority has not

taken any decision whether the Renewal Licence forwarded by the

State Licensing Authority in Form 26-I is approved by the Central

Licence Approving Authority or not.

23. The petitioner has participated in the tender process by disclosing the

Renewal Licence issued by the State Licensing Authority under Form

26-I but the Central Licence Approving Authority has not approved

the same and thus, this Court did not find any illegality in rejecting

the technical bid of the petitioner as the Renewal Licence relied by the

petitioner is not approved by the Central Licence Approving Authority.

15

24. In view of the above, WPA No. 20748 of 2026 is thus dismissed.

Parties shall be entitled to act on the basis of a server copy of the

Judgment placed on the official website of the Court.

Urgent Xerox certified photocopies of this judgment, if applied for,

be given to the parties upon compliance of the requisite formalities.

(Krishna Rao, J.)