Provision of unlicensed medicines for unmet medical needs

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We recognise that there may be instances when it is appropriate for Healthcare Professionals to seek an unapproved medicine or vaccine for treatment use for a patient where no satisfactory alternatives exist. Our policy and programmes may provide an option for providers and patients faced with these challenges.

Provision of unlicensed medicines for unmet medical needs in various places and circumstances may be referred to as single patient use, named patient use, compassionate use, expanded access, special access, managed access, importation of unlicensed medicine, or other names.


If you are a Healthcare Professional who would like to request compassionate use of a GSK investigational medicine for a patient, please use the GSK Compassionate Use Request Portal.  You will need to create a profile before you can submit your request.

In order to handle your enquiry, we are required to record and maintain the personal information that you have provided to us.  This may include your name and contact details. This personal information will be processed solely for the purpose of dealing with your enquiry.  More detailed information on the processing of your personal information is available from our Privacy Notice.

Patients themselves cannot make a request for compassionate use and need to contact their Healthcare Professional.

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The Importation of Unlicensed Medicines programme may provide a mechanism for a physician to treat a patient with a GSK medication that has been approved in a major market but is not yet approved in their country for the same indication.

Patient eligibility includes:

  • Serious or life-threatening disease
  • No alternative treatments available
  • Inability to participate in a clinical trial
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For oncology, please contact MedicineAccess@Clinigengroup.com.

For any other request please connect with your local GSK entity via Worldwide | GSK

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GSK India has been taking steps to make a difference in areas, including Anti-microbial resistance (AMR), Dermatology, Hypothyroidism, Paediatric vaccines, Adult vaccines and Specialty.

  • Anti-microbial resistance (AMR)

    GSK has undertaken several initiatives to address issues related to AMR in India by participating in local, regional and national meetings with emphasis on the right use of antibiotics and improve ways to disseminate scientific information about various types of medicine

    - Over 250 internal medical-led scientific presentations to ~25,000 HCPs in AMR
  • Dermatology

    GSK India continues to undertake efforts to increase awareness on rational topical steroid antibiotic usage, accurate diagnosis and effective management of common skin disorders and other dermatological conditions.

    - 351+ Dermatosis case study clinics organised
    - 3,000+ Institutional dermatologists engaged in scientific case-based discussions on different types of skin ailments.
    - Collaborated with 6 national and international experts
  • Hypothyroidism

    GSK India conducts  Cross Specialty Experts Symposium (CREST 2.0) meetings on 'Thyroid Dysfunction in Women'.

    - ~900 HCPs trained on optimal management of hypothyroidism
  • Adult vaccines

    As a leading player in the adult immunisation segment in India, GSK continues to introduce innovative products to the market.

    - Received authorisation for Shingrix Herpes Zoster Vaccine (recombinant, adjuvanted) along with an approval for carrying out Phase III clinical trials for fulfilling the unmet needs of Indians at risk of contracting Herpes Zoster

    - Regulatory extension for the use of Fluarix Tetra in individuals aged 65 years and above.
  • Paediatric vaccines

    From discussions with obstetricians to having a medical team collaborate with experts to deliver new data for Neonatal Pertussis and Hepatitis A, GSK India has highlighted the company’s advocacy in Paediatric vaccination.

    - 533 one-on-one interactions conducted for Paediatric Vaccine awareness
  • Specialty

    In 2023, GSK recruited patients for a PRISM study, a Phase IV study in patients of severe asthma with eosinophilic phenotype.

    - Made presentations for 70+ CMEs and educated 2,500+ HCPS through external experts
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