Regulatory Compliance
The law we operate under, and how we keep to it in practice.
Framework
Our operations are governed principally by:
- Drugs and Cosmetics Act, 1940 and the Rules made under it, including Schedule M on good manufacturing practice.
- Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, which governs what may be claimed about a medicine in public.
- Drugs (Prices Control) Order, where a product falls within its scope.
- Legal Metrology Act, 2009 for pack declarations.
- Food Safety and Standards Act, 2006, for nutraceutical products.
- Uniform Code for Pharmaceutical Marketing Practices, which governs interactions with prescribers.
Licensing
Manufacture and sale are carried out under licences issued by the State Drugs Controller. Licence numbers are printed on every pack. Our distributors hold their own wholesale or retail drug licences, which we verify before appointment.
Labelling and packaging
- Every pack carries the generic composition, strength, batch number, date of manufacture and date of expiry.
- The manufacturer's name, address and licence number are printed on the pack.
- Prescription products carry the Rx symbol and the statutory caution.
- Storage conditions and the "keep out of reach of children" warning appear on the label.
- Maximum retail price is printed inclusive of all taxes, as required.
Records
Batch manufacturing records, analytical records and distribution records are retained for the period required by the Rules, so that any pack in the market can be traced back to its batch record and its release data.
Promotion
Promotional material is reviewed before release against the approved pack insert. We do not advertise prescription products to the general public, and we do not make claims of cure. Our published position on this is set out in the Code of Ethics.
Product recall
Where a quality defect is confirmed, the affected batch is traced through distribution records, recalled from the channel and reconciled. The relevant Drugs Control authority is informed. Complaints that could indicate a defect are handled through pharmacovigilance.