The Indian Pharmaceutical Industry today is in the front rank of India's science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisti-cated antibiotics and complex cardiac compounds, almost every type of medicines is now made in India.
Along with the complexity of the growing market the requirements of the packaging materials are also becoming complex. Glass as the preferred packaging material in the earlier days, being inert, did not pose any problem and in as much as it was properly closed the pack was safe for any pharmaceutical packaging. However with the advent of plastics and other polymeric materials for packaging the situation has changed, as the problem of interaction with the product by the packaging material is a major concern to the users.Newer materials both for packaging and the product have thrown open newer challenges to the packaging technologists as it has to comply with the strict and stringent regulations applicable to the pharma industry.
Regulation in packaging
The pharmaceutical industry is one of the most highly regulated industries in the world. Specific laws and directives govern each step from the product development and manufacture to the packaging and disposal.
In India there are two major government agencies responsible for drug regulation and control:
1. The Drugs Controller General of India (DCGI), and
2. The State Food and Drug Administrations (FDAs).
State FDAs monitor the drug manufacture, sale, and testing by companies including packaging in their jurisdiction. The guidelines for packaging generally defines the type of container to be used, dividing into parenteral (glass or plastic) and non-parenteral (glass, plastic or metal) along with pressurised containers and bulk containers. Closure types are also listed including tamper evident and child resistant caps. Liners are also given prominence with inner seals and elastomers when used as closures.
The guidelines generally give the suitability of the packaging components in term of the physical, chemical and biological characteristics, specification and tests to be applied, stability and compatibility considerations and the involvement of adhesive and inks.
The ingredients added to the plastics such as plasticisers, pigments etc. sometimes leach from the plastics into the product. Also certain ingredients of the product bind or get absorbed into the plastics. These are required to be tested with the extractive testing. The pharmacopoeia of different countries also provides lists of plastics that are permitted for use for pharmaceutical containers. If a material is not listed in the pharmacopoeia then generally reference is made to further directives dealing with plastic materials in contact with food.
Labelling
Just as the container cannot be separated from the product in regulatory or technical terms, the label and leaflet are also intimately connected and in pharmaceuticals the term labelling generally includes both labels and leaflets.
The function of a label and a leaflet is to inform the patient, the pharmacist, wholesalers to control the product in terms of its distribution and medical aspects and to reduce the risk of product liability claims.
The patient has the label on the primary container and the packaging insert, the wholesalers has the carton and pallet labels, and the pharmacist has the immediate container label, carton label, packaging insert and possibly the summary of product characteristics (SPC). The doctor looks at the SPC or any such information.
All the information supplied should be accurate and consistent both scientifically and legally.
General labelling requirements for the primary pack of pharmaceutical products are:
- Product name
- Active ingredients
- Pharmaceutical form and contents
- List of excipients (all for ophthalmic or parenteral) (any with recognizable effect)
- Method and route of administration
- Special warnings
- Expiry date
- Special precautions
- Name and address of authorisation holder
- Authorisation number
- Manufacturing batch number
- Instructions for use for self-medication product.
Some smaller packs such as blister packs are sometime exempted from full labelling
- Product Name
- Authorisation holder's name
- Expiry date
- Batch number Leaflet
All products must contain a patient leaflet unless all the information can be conveyed on the outer packaging label. The content of the leaflet and order of presentation must be as follows.
1. Identification of Product.
2. Name of product, statement of active ingredients, pharmaceutical form, pharmaco-therapeutic group, name and address of authorization holder.
3. Therapeutic indications
4. Information needed for taking the product.
5. Contra-indications, precautions for use, interactions, special warnings, including use in pregnancy, elderly, effect on ability to drive vehicles and details of any excipients which may be important for safe and effective use of the product.
6. Instructions for use.
7. Dosage, method and route of administration, frequency of administration, duration of treatment where limited, action to be taken in the case of an overdose or lack of dosing and risk of withdrawal effects where possible.
8. Undesirable effects.
9. Effects that can occur under normal use of the product and action to be taken.
10. Expiry date.
11. Warning against use of the product after the date, appropriate storage precautions and warning against visible signs of deterioration.
12. Date on which package leaflet was last revised.
The leaflet must be written in clear understandable terms and has to be in the official language of the country.Package and environment
Of particular concern is the amount of packaging used and how it is disposed off. The concerns of packaging with respect to the environment are waste disposal, Ozone depletion and transport of harmful substances. As regards the waste disposal problems are concerned the approach has been to
- Reduce the quantities of packaging material and therefore the waste.
- Reduction in harmfulness of waste.
- Promotion of reuse of packaging
- Recycling and recovery of packaging waste.
Many countries have set targets of waste recovery thus necessitating the need for an efficient return collection and recovery system. Also it is necessary in many countries that the nature of the plastic to be identified by proper marking.
Pressurised aerosol plays a major part in pharmaceuticals and in many cases are perfect package efficiently protecting the product and dispensing an accurate dosage of the contents. A mixture of chlorofluorocarbons (CFCs) was used as propellant in such pack systems. This was causing depletion of the ozone layer. As a result their production have been stopped in many countries. Alternative propellants are being developed and are being introduced in the market each day.
Hazardous Products
If the pharmaceutical products are hazardous in nature special regulations with respect to shipping of this either by air or by sea are in vogue. The packs for these hazardous products should comply with Shipping regulations (IMDG or IAATA)
Barcodes
Bar codes are generally used as a product identification tool for use in the retail chains or for in-house applications like inventory management, sales tracking etc.
Though EAN 13 is the most popular barcode for retail marketing special barcodes are developed for the pharmaceutical industries. EAN-13 is used worldwide for marking retail goods. The symbol encodes 13 characters: the first two or three are a country code which identify the country in which the manufacturer is registered (not necessarily where the product is actually made). The country code is followed by 9 or 10 data digits (depending on the length of the country code) and a single digit checksum.
Code 128 provides excellent density for all-numeric data and good density for alphanumeric data. It is often selected over Code 39 in new applications because of its density and because it offers a much larger selection of characters. The Code 128 standard is maintained by AIM (Automatic Identification Manufacturers).
Code 128 is generally used on the shipping container for coding additional informations such as batch Number, lot number etc.The pharmaceutical industry also uses some variations of the general codes for specific end uses in the industry. Some of them are: The Pharma Code is used for quality control and product identification for pharmaceutical products. Often one or more of the bars have different colour. The colours can be used to display extra information about the product each company can use different colouring for the bars, for example a blue bar may mean the product may be taken orally.
The other main pharmaceutical barcode types are IKS, a variation of EAN 13, PZN (Pharma Zentralle Numer), MSI and IMH, used by the Italian health Ministry The bars encode a number which is not usually displayed.
Other pharmaceutical barcodes are often variations of standard labelling symbologies. Care should be taken as sometimes the displayed number is not the number encoded in the bars.
The pharma industry the world over is a highly controlled industry. The regulations with respect to packaging are very stringent as the product is meant for such applications such as direct injections, intravenous fluids that are directly injected into the blood stream.
A little mishap due to negligent or incompatible package will cause huge damage to the company by way of claims. The mandatory labelling requirements for safe use and dosage of the product is a must on the entire product. Various countries have different formats but the basic requirements remain the same - make the user aware of the safe usage of the product
-- The author is joint director, SIES School of Packaging / Packaging Technology Centre, Navi Mumbai