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The Drugs And Cosmetics Act, 1940
Article 226 in The Constitution Of India 1949
The Companies Act, 1956

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Madras High Court
M/S.El-Shaddai Biologicals ... vs The Drugs Controller General(I) on 1 March, 2011

DATED: 01.03.2011

CORAM

THE HONOURABLE MR. JUSTICE VINOD K.SHARMA

W.P.No.22080 of 2010 and M.P.No.2 of 2010

M/s.El-Shaddai Biologicals Limited,

Rep. by its Managing Director ... Petitioner

Vs.

1. The Drugs Controller General(I),

Directorate General of Health Services,

O/o Drugs Controller General I

(Biological Division),

FDA Bhawan, Kotla Road,

New Delhi.

2. The Assistant Drug Controller,

O/o. Assistant Drug Controller (India)  Port,

Central Drugs Standard Control Organization,

Customs House, Air Cargo Complex,

Meenambakkam, Chennai. ... Respondents

Writ petition has been filed under Article 226 of the Constitution of India to issue a writ of Certiorarified Mandamus calling for the order of the second respondent in File No.6-9/MP/2010/1539 dated 15.6.2010 and the consequential order of the first respondent in File No.6-5/26/05-BD-III (Renewal  09) dated 31.08.2010 and quash the same and consequently directing the respondents to retest the imported products by an third laboratory of the sample Normal Human Intrvenous immunoglobulin (PH4) for intravenous injection pursuant to the contradictory test reports by the laboratories.

For petitioner : Mr.K.M.Vijayan, S.C.

For respondents : Mr.S.Thiruvengadam

Addl. Central Govt. Standing

Counsel

*****

O R D E R

The petitioner M/s.EL-Shaddai Biologicals Limited, a company registered under the Companies Act has approached this court with a prayer for issuance of a writ in the nature of Certiorari for quashing the impugned order dated 31.08.2010 which reads as under: "File No.6-5/BP-26/05-BD-III (Renewal-09)

Directorate General of Health Services

O/o Drugs Controller General (I)

(Biological Division)

FDA Bhawan

Kotla Road,

New Delhi.

Dated:31.08.2010

To

M/s.El-Shaddai Biologicals Ltd.,

No.7, 5th street, Dr.Thirumoorthy Nagar,

Nungambakkam, Chennai 600 034.

Sub: Test & examination report of Human Immunoglobulin (pH 4) 2.5. gm/50ml vide batches No.20091113 expiry date: 10/2012 imported from M/s.Harbin Sequel Biolengineering Pharmaceutical Company, China  Positve for HCV and Indeterminate for HIV  regarding. Sir,

Please refer to your letter No.NIL dated 12 July 2010 regarding subject cited above. Enclosed herewith please find the copies of test reports on the subject mentioned blood product received from various testing laboratories. The COA attached herewith reveal that your imported consignment of Human Immunoglobulin (pH 4) 2.5gm/50ml manufactured at M/s.Harbin Sequel Bioengineering Pharmaceutical Company, China do not conform to official pharmacopeia as the same fails to pass the tests HCV & HIV. In view of the above you are requested to re-export the whole lot of consignment to its country of origin."

2. The petitioner is a high-end critical care and biologicals marketing company which imports Immunologicals, vaccines and molecular biotechnology products. The petitioner was awarded a Rate contract by Kerala Medical Services Corporation, Trivandrum. The petitioner had agree to supply IVIG to them in bulk supplies for the Rate Contract.

3. The petitioner imported Normal Human intravenous immunoglobulin (IVIG) [PH4] for intravenous injection, from the Chinese Manufacturer, viz., M/s.Haribin Sequel Bio Engineering Pharmaceutical Limited. The petitioner imported 38,150 vials of 5 grams, 20,300 vials of 2.5 gram and 28,995 vials of 0.5 gm which were successfully tested negative for antibodies of HIV 1 and HIV 2 and were distributed in the market.

4. The petitioner thereafter imported another consignment of 4000 vials of Normal Human Intravenous Immunoglobulin (2.5 gms) out of 9883 vials. The samples were certified to be good by the manufacturer. The samples were sent for test under the provision of Drugs and Cosmetics Act to National Aids Research Institute and National Institute of Virology.

5. The report of the laboratory read as under:

HIV 1 & HIV 2 were reported as "Indeterminate" by National Aids Research Institute which is in medical terms showing to that the antibodies for HIV 1 & HIV 2 were not conclusively positive. Whereas report from other laboratory on test of HCV and HbsAg were declared negative i.e. to say that the sample passed the test.

6. In view of the report "Indeterminate", the samples were sent for second test to Christian Medical College, Vellore, which reported HIV 1 & HIV 2 negative, whereas the contents of HCV and HbsAg were declared positive, resultantly, the samples were said to have failed the test for use.

7. The consignments imported by the petitioner were cleared by the customs, on the basis of letter of Guarantee of the petitioner. In view of the report from the National Aids Research Institute, Pune and Christian Medical College, Vellore, the petitioner was directed to surrender the entire quantity of the products to the Customs.

8. After passing of the order dated 15.6.2010, the Drugs Controller General (I), passed the impugned order referred to above directing the petitioner to re-export the whole lot of consignment to its country of origin.

9. The petitioner challenged the impugned order primarily on the ground that in the first test conducted by the National Aids Research Institute in which HIV 1 and 2 reported "Indeterminate", whereas Institute of Virology C.M.C. had reported "Negative" for HIV 1 and 2 and "Positive" for HCV and HBsAg which already stood passed and was not a subject matter of retest.

10. This contention of the learned counsel for the petitioner cannot be accepted, as the laboratory to whom reference was made had the jurisdiction, to report about the product as a whole, as it was a matter concerning health of the public at large.

11. However, keeping in view of the fact that the reports by different tabulation were contradictory, this Court directed the second respondent to send the samples to an independent laboratory, i.e. National Institute of Biologicals, Government of India. The Govt. Laboratory on test reported as under: "I am directed to refer to your letter No.TOD/AIR/CHE/25/0031/10/343, dated 06.01.2011 on the above subject and to say that the above sample of Human Immunoglobulin (pH 4.0) I.V. Injection 2.5 g/50 (Sample No.IMP-615) Batch No.20091113, manufacturing date 11/2009: Expiry date 10/2012. Manufactured by M/s.Harbin Sequel Bioengineering Co. Ltd., China and imported by M/s.El-Shaddai Biologicals Ltd., Chennai has ben tested and the Certificate of Analysis (Analytical Report No.N.1-5/2011-SRRD/DKL dated 24.01.2011) is enclosed. Yours faithfully,

sd/-

(Ashis Barua)

JTO & OI/c SRRD

****

NATIONAL INSTITUTE OF BILOGICALS

(Ministry of Health & Family Welfare)

A-32 Sector-62, NOIDA 201 307

RESULTS OF TRANSFUSION TRANSMITTED INFECTION TESTING OF BOLLD PRODUCTS Dated 20.01.2011

1. Analytical Report No: N-1-5/2011-SRRD/IDKL

2. Name of the Product: HUMAN IMMUNOGLOBULIN (pH4.0) I.V. INJECTION 2.5g/50 ml

3. Name of the Manufacturer:

M/s.HARBIN SEQUEL BIOENGINEERING CO. LTD., CHINA

4. Name of the Importer:

M/s.EL-SHADDAI BIOLOGICALS LTD., CHENNAI

5. Sample forwarded by: ADC(I), CDSCO, CHENNAI

6. Sample No.IMP 615

7. Lot No.20091113

8. Manufacturing date: 11/2009

9. Expiry date: 10/2012

10.Details of testing:

S.No

Test(s) Conducted

Name of the kit, Lot no: Expiry date

Date of Testing

Result

1

HIV1&2 Antibody

1. ELISA: VIRONOSTIKA HIV Ag/Ab Lot: A61GZ Expy: 28.07.11 14.1.11

Non Reactive

2. CONFIRMATORY ASSAY: INNO-LIA HIV 1/II SCORE Lot: 206153 Expiry: 31.05.11 18.1.11

Negative

2

HCV Antibody

1. ELISA:

SD HCV ELISA 3.0

Lot: 222035

Expy: 31.5.11

14.1.11

Non Reactive

2 CONFIRMATORY ASSAY:

INNO-LIA HCVSCORE Lot: 2077353 Expy:30.06.11

18.1.11

Negative

REMARKS: HUMAN IMMUNOGLOBULIN (pH4.0) I.V. INJECTION 2.5g/50 ml: LOT No.20091113 IS NEGATIVE FOR HIV = Ab and HCV Ab. Sd/- sd/-

Signature of the Analyst Signature of the Lab. Head

Dr.CHARU, S.III Dr.C.Sokney Hode Sc gradeI

Name & Designation Name & Designation

Date: 24.01.11 Date: 24.1.11"

12. In view of the report of the National Institute of Biologicals, the impugned order cannot be sustained, as the product has been declared fit for use by the public. In view of the positive report by Central Govt. Laboratory, no useful purpose would be served to remand the case back for fresh decision, as it will unnecessarily delay the use of imported medicine which is fit for use.

13. Consequently, the writ petition is allowed. Impugned order is set aside and a Writ in the nature of mandamus is issued directing the respondents, to permit the petitioner to supply the products under Rate Contract to Kerala Medical Services Corporation, Trivandrum. No costs.

vaan

To

1. The Drugs Controller General(I),

Directorate General of Health Services,

O/o Drugs Controller General I, (Biological Division),

FDA Bhawan, Kotla Road, New Delhi.

2. The Assistant Drug Controller,

O/o. Assistant Drug Controller (India)  Port,

Central Drugs Standard Control Organization,

Customs House, Air Cargo Complex, Meenambakkam,

Chennai