“India is in a phase of development and many Indian companies are going for generic devices being used as pen and auto injectors. These devices have a huge segment for diabetic and rheumatoid arthritis patients,” said Suman Kumar, head injectables packaging development, Macleods Pharmaceuticals. He described the criteria for package design of a medical device and  the requisite regulatory standards considerations for the same.

“Last year, the device market globally was USD 495 bn and India itself is contributing currently USD 8 bn. So, till 2029 it has been projected that it will be from USD 8 bn to USD 10 bn in India.” he added.

He briefed about the regulatory considerations and standards, which will be required to develop the packaging material and also combination products, defined under 21 Code of Federal Regulations (CFR) 3.2(e) is nothing but a combination of two different types of products, or three different kinds of products i.e. one is a drug product, second is the drug device and the third is the biological drug product.

There are several types of medical devices available for injectable drug delivery. Among them, auto injectors and pen devices are most commonly used however they differ from each other based on mechanism. The primer is equipped with prefilled syringes, automatically inserts the needle and performs the injection via spring-driven action. The latter is usually cartridge based syringes. 

“ISO 16775 has been revised. Now under this it lays down procedures for two subdivisions ISO 11607-1, ISO 11607-2. These are for terminally sterilized products, but one contains your material characteristics, your sterile barrier requirements and secondary view packaging validation like how much it is sealing. And for requirements for regulatory purposes, to govern the quality management systems ISO 13485 is considered.” he explained. He mentioned the general regulatory considerations for medical device development such as description, suitability, quality control and stability.

The Food and Drug Administration (FDA) has come up with a streamlined approach with two sets of standards. First is quality standards, American regulations, and second is Current Good Manufacturing Practice (cGMP) based manufacturing. These regulations are mainly related to your manufacturing of these devices at the plant level of shop permit, but first is your quality standard regulation. 

He continued to highlight the challenges faced during packaging development of medical devices. These can be either drug related or device related. A major issue prone is change in viscosity causing difficulty in injection, modification of internal diameter of tube and also switching from vial to medical device.

Macleods Pharmaceuticals, established in 1989, are engaged in developing, manufacturing, and marketing a wide range of formulations across several major therapeutic areas including anti-infectives, cardiovascular, anti-diabetic, dermatology and hormone treatment.