India Committee withdraws complaint regarding alleging illegal import of Vectobac 12 AS of Sumitomo Chemicals India

Date:08-27-2013

The India Committee withdraws the complaint made by All  India  Biotech Association (AIBA) regarding alleging illegal import of Vectobac 12 AS (B.t.i) from Sumitomo Chemicals India, considering the reply filed by Sumitomo Chemicals India Pvt.Ltd Mumbai (SCIPL). The Committee considered the reply submitted by SCIPL with reference to the  issues raised by All India Biotech Association (AIBA) and decided that SCIPL was complying with the conditions of registration of Vectobac 12 AS (B.t.i).

Previously, the AIBA alleged that Sumitomo Chemicals India violated  the terms of registration on several counts. The Sumitomo Chemicals India gave the reasonable explanation about it.

The Committee noted that the product was registered for import from Valent Bioscineces, USA. It involved two steps, viz. (i) manufacture of the product in USA, and (ii) its import in the importing country.

Therefore, its manufacturing activity is governed by the regulations prevalent in the country of source, while its import is to be governed by the regulations in the country of import (India). The case has been examined in this perspective.

US EPA, being the  regulatory authority of the exporting country, has registered Vectobac 12 AS in favour of Valent Biosciences Corporation Inc vide Registration No. 73049-38 mentioning the Est. No. of its pesticide-producing  site  (i.e. A To Z Drying) 33762-IA-1 on the label of the product approved by  it. Thus, it is evident  that M/s A To Z Drying  is an approved site for manufacture of Vectobac 12 AS, registered by US EPA in favour of M/s Valent Biosciences Corporation, Inc. Toll manufacturing is officially permitted  in USA..To prove this  fact, relevant admissible documents issued by the regulatory authority, i.e. US EPA, have been submitted by M/s SCIPL.

Similarly, as far as the import of the product in India is concerned, it is governed by the regulations prevalent for the time being in force, i.e. the Insecticides Act, 1968 (the Act) and  the Rules framed thereunder. The Certificate of Registration was issued  after due compliance of  the relevant guidelines, framed by  the Registration Committee  (RC) and also after detailed deliberation by the Committee. The product is being imported by SCIPL from Valent Biosciences, USA, the source of import registered in India.

The  Committee was of  the opinion that in case AIBA  desires to challenge the competence of M/s A to Z Drying to Toll Manufacture the product for M/s Valent Bioscience corporation, which is permissible as per the relevant laws of the country of manufacture (USA), it can do so by challenging it before the US EPA. As long as the import of  the product is from the approved source, it does not violate the conditions of the certificate of registration and, thus, does not in turn violate the provisions of the Act.

The Committee also noted that the chemical composition of the product is registered on dry-weight basis of the active ingredient in the country of manufacture (USA), while the same is registered  in India on aqueous slurry basis. The former shows  the water among other  ingredients. The ultimate product  is  an AS  formulation. SCIPL  have  submitted a copy of the US EPA document showing that the two are equivalent. As far as labeling is concerned,  the  product  is  labeled  in  the  US  as  per  the  label  approved  by  US EPA, whereas  the  product  is  labeled  in  India  as  per  the  label  approved  by  the  RC.  The directions for use, storage, etc are country-specific depending on the climatic conditions. They are approved accordingly on the labels by the respective regulatory authority.

The  Committee is also satisfied that the difference in the signatures of Mr.  Alston Penfold is due to the fact that there are two persons with the same name. The difference is only in their middle  name, viz. Mr. Alston Jason Penfold and Mr. Alston William Penfold. The copies of their passports have been attached by SCIPL.

In view of above facts, Committee decided that SCIPL is complying with the conditions of registration of Vectobac 12 AS (B.t.i).