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Pharmexcil urges exporters to act swiftly as Botswana mandates pre-shipment inspection effective from July 1, 2025
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Shardul Nautiyal, Mumbai
July 10 , 2025
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In a crucial regulatory update that could significantly impact India’s pharmaceutical exports to Botswana, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged coordination on priority with Quntrol Laboratories Private Limited to comply with Botswana’s newly mandated Pre-Shipment Inspection (PSI) requirement, which is effective from July 1, 2025.
The move comes in response to formal communication from the Botswana Medicines Regulatory Authority (BoMRA), which has announced the implementation of PSI for all consignments of certain pharmaceutical products. The requirement is particularly targeted at medicines exempted from registration and those manufactured at specific facilities identified by BoMRA.
According to officials, this critical initiative is aimed at strengthening quality assurance and safeguarding public health. It places an onus on exporters to demonstrate compliance with Botswana’s regulatory and quality standards before shipment.
To facilitate this process, BoMRA has appointed Quntrol Laboratories Private Limited as the designated agency responsible for inspection and testing of consignments, certification of compliance with applicable regulatory standards, and issuance of a Certificate of Regulatory Inspection and Approval (CRIA) for eligible shipments.
Key compliance requirements for exporters stipulate that exporters must obtain the CRIA from Quntrol Laboratories before goods are cleared at Botswana ports of entry. Presentation of a valid CRIA will be a mandatory condition for consignment clearance. Non-compliance may result in denial of entry or further regulatory consequences.
Raja Bhanu, director general, Pharmexcil stressed the importance of proactive compliance with the PSI process to avoid any trade disruption. Members are advised to initiate timely coordination with Quntrol Laboratories and ensure compliance with the new pre-shipment requirements.
Pharmexcil has provided direct email contacts —dgdesk@pharmexcil.com and regulatory@pharmexcil.com— for members seeking clarifications or procedural support.
This development places added responsibility on pharmaceutical exporters to integrate inspection timelines into their supply chain planning to avoid bottlenecks or delays.
BoMRA clarified that this new mechanism is part of its larger agenda to strengthen the oversight of pharmaceutical imports, especially those not subjected to formal registration processes.
The PSI will act as a safeguard, ensuring that products entering Botswana —even under registration exemptions — still meet stringent quality requirements.
Botswana imports mixed medicaments for prophylactic and therapeutic uses from amongst others, South Africa, India, the United States of America, Canada, Malaysia, Italy, Zimbabwe and Germany. In Botswana, vaccines (veterinary and human) are purchased mainly by the Public Sector and administered by public health institutions to individual patients. Vaccines are largely imported.
Regulation of the import, export and manufacture of drugs is undertaken by the Drug Regulatory Unit (DRU) whose mandate is to implement the provisions of the Drugs and Related Substances Act, 1992 (Drugs Act) which forms the legislative framework of the National Drug Policy. The broad aim of the DRU is to institute a system which subjects all pharmaceutical products to pre-marketing evaluation, give marketing authorisation and post-marketing review to ensure that they conform to required standards of safety, quality and efficacy.
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