LifeSpark Pharma — Oncology · Pulmonology · Cardiology · Diabetology · Orthopaedic · Neurology · Nutraceutical · OTC — Partner With Us
LIFESPARK Pharma Private Limited

Regulatory Compliance

The law we operate under, and how we keep to it in practice.

Approvals and oversight

Every formulation in our ethical, superspeciality and OTC portfolio is approved by the Drugs Controller General of India.

Our corporate logistics, distribution and partner manufacturing setups follow the guidelines of the Central Drugs Standard Control Organization and the Maharashtra State FDA.

  1. National approval DCGI Drugs Controller General of India
  2. Central CDSCO Standards & control State Maharashtra FDA Licences & inspection
  3. Operating under both LifeSpark Pharma Formulations · distribution · partner plants
Framework

The law our operations are governed by

  1. 1940

    Drugs and Cosmetics Act

    And the Rules under it, including Schedule M on good manufacturing practice.

  2. 1954

    Drugs and Magic Remedies Act

    Governs what may be claimed about a medicine in public.

  3. 2006

    Food Safety and Standards Act

    For our nutraceutical products.

  4. 2009

    Legal Metrology Act

    For the declarations on every pack.

  5. Ongoing

    Drugs (Prices Control) Order

    Where a product falls within its scope.

  6. Ongoing

    UCPMP

    Uniform Code for Pharmaceutical Marketing Practices — interactions with prescribers.

Labelling and packaging

What every pack must tell you

Illustrative pack — not a real product.
  1. 1Generic composition and strength
  2. 2Batch number, manufacturing and expiry dates
  3. 3Manufacturer's name, address and licence number
  4. 4Rx symbol and the statutory caution
  5. 5Storage conditions and "keep out of reach of children"
  6. 6Maximum retail price, inclusive of all taxes
In practice

How we keep to it, day to day

  • 01

    LicensingManufacture and sale run under licences issued by the State Drugs Controller, printed on every pack. Distributors hold their own drug licences, verified before appointment.

  • 02

    RecordsBatch, analytical and distribution records are kept for the period the Rules require — so any pack in the market traces back to its batch and release data.

  • 03

    PromotionPromotional material is reviewed against the approved pack insert. No prescription product is advertised to the public, and no claim of cure is made.

Our published position on promotion is set out in the Code of Ethics.

Product recall

If a defect is ever confirmed

Complaints that could indicate a defect are handled through pharmacovigilance.

  1. 1

    Defect confirmed

    A quality defect is confirmed — often first raised as a complaint through pharmacovigilance.

  2. 2

    Batch traced

    The affected batch is traced through distribution records.

  3. 3

    Recalled & reconciled

    Stock is recalled from the channel and reconciled against what was shipped.

  4. 4

    Authority informed

    The relevant Drugs Control authority is informed.

For buyers and auditors

The statutory document set

Documents commonly requested in tenders and export enquiries.

Request the document set
  • Drug Manufacturing Licence
  • GMP / WHO-GMP certificate
  • ISO certificate
  • GST registration
  • Certificate of Incorporation
  • Product-wise Certificate of Analysis
Where to next
Science & Quality overview How a product is developed, made, tested and monitored. Read more Quality assurance The tests every batch faces before release. Read more Pharmacovigilance How a side-effect report is received and investigated. Read more