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Shardul Nautiyal, Mumbai June 07 , 2023
The Small & Medium Pharma Manufacturers Association (SMPMA) has urged the Union health ministry to exempt WHO GMP approved units from joint inspections for getting loan license and making SUGAM portal user friendly. State Licensing Authority (SLA) and Central Licensing Authority (CLA) joint inspection is required for loan license applications.

SMPMA chairman Nipun Jain has raised these issues in a letter to Aaradhana Patnaik, joint secretary, Union health ministry. In the letter, it has been urged to exempt WHO GMP approved units as they have already been approved by the Centre and State inspection teams.

There are a sizable chunk of pharma manufacturing units falling under the small and medium sector providing quality medicines at an affordable cost to the public. However, we are facing certain constraints on a regular basis as follows needed to be removed very urgently.

As per the SMPMA letter, the Central Drugs Standard Control Organisation (CDSCO)’s online portal SUGAM is not ‘sugam’ (happy) at all. It is very slow and not updated. Due to which, a lot of already approved formulations / APIs are not listed. This ambiguity is preventing companies from getting licenses for old established lists of products. The SUGAM portal is so slow that it takes a lot of time to search the specific drug. We, therefore, request the Union health ministry to please take appropriate steps so that pharma manufacturers do not face problems because of the above mentioned constraints.

The letter further stated that a lot of exporters are exporting Indian Pharmacopoeia (IP) products which are accepted by overseas customers, but our customs officials are more than eager to stop them as they say IP products are not valid for exports. It has been urged to kindly issue an advisory to the effect that IP products can be exported if there is a valid export order.

A copy of the same has been sent to the Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi.

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