IPC invites bids for supply of Ref Std, Impurities from Pharma Mfrs

A pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances

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IPC
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The Ghaziabad-based Indian Pharmacopoeia Commission (IPC) has invited sealed and super-scribed bids for supply of candidate material for reference standard and pharmaceutical impurities from reputed and experienced Indian manufacturers as per new public procurement policy for MSMEs effective from April 1, 2021.

A pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.


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Laboratory
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Pharmaceutical impurities are either naturally occurring or added during synthesis of a drug. During production, impurities may be purposely, accidentally, inevitably, or incidentally added into the substance. Standards have been established by various organizations that attempt to define the permitted levels of various impurities in a manufactured product.


Click below links for:

List-of-145-Impurities-Dec-2019

List-of-594-Reference-Substances-Dec-2019


As per the IPC notice, each impurity must be supplied along with Impurity Material Information Form” and other supporting documents such as Certificate of Analysis (CoA) etc. Procedure for calculating local content under preference to Make In India would be as per new public procurement policy for MSMEs.


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The reference standard should be of the highest purity possible. The drug substance may require further purification to become a reference standard (additional purification steps used for a drug substance should be fully described and included in any regulatory filing).

This bid is reserved for Class I and Class II bidders only as per make in India Policy (DPIIT Order dated September 16, 2020). Participating bidders need to submit relevant make in India authorization certificate.

The bidder should be reputed and experienced manufacturer. He/she should have valid manufacturing license/approval document including undertaking must be enclosed along with the technical bid.

Tender Forms can be downloaded from our website www.ipc.gov.in only. Downloaded Tender document must be submitted with a Demand Draft(s) as mentioned, in favour of “Indian Pharmacopoeia Commission” payable at Ghaziabad. Sealed tender duly super scripted can be submitted to the office of the Indian Pharmacopoeia Commission, Ghaziabad through Post/ Courier also, on or before the due date of April 23, 2021.

Pre bid meeting date and time is April 8 2021, 2 pm. The last date and time for downloading tender forms is April 22, 2021 (upto 5 pm). The date and time of opening of technical bids is April 23, 2021, at 11:30 am. The date and time of opening of price bids would be intimated later.

The bids are intended for Supply of “Candidate Material for Reference Standard,” at IPC, Ghaziabad is as per Schedule of Requirement (SOR). Validity of tender quoted rates must be valid for 18 months from the last date of tender. If required, the competent authority may extend the contract for another 18 months on same rates and terms and conditions subjected to the satisfactory performance of the manufacturer.

This bid is reserved for Class I and Class II bidders only as per make in India Policy (DPIIT Order dated September 16, 2020). Participating bidders need to submit relevant make in India authorization certificate. Bidding document may be amended any time prior to closing date and time for submission of tenders.

Therefore, bidders are advised to regularly check IPC website for tender relevant amendment/changes (if any). A pre-bid meeting may be attended by authorized representative of prospective bidders for any doubt/clarifications at the Commission as per scheduled date & time. The meeting will be held remotely via video conferencing facility. The link for same will be shared through IPC website.

In exercise of powers conferred in Section 11 of the Micro, Small and Medium Enterprises Development (MSMED) Act 2006, the Government has notified a new Public Procurement Policy for Micro and Small Enterprises (MSMEs) effective from April 1, 2021.

The policy mandates that 25% of procurement of annual requirement of goods and services by all central ministries/public sector undertakings will be from the micro and small enterprises.

The government has also earmarked a sub-target of 4% procurement of goods and services from MSEs owned by SC/ST entrepreneurs out of above said 25% quantity.


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