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Regulatory compliance with pharma packaging

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Globally, pharma regulatory agencies are becoming stringent and to comply with their requirements, and the Indian pharma companies need to keep updating themselves regularly. For instance, recently, the EU FMD directive has become mandatory and companies looking to export to these countries have to implement it. Besides this, a lot more regulatory changes happening. This panel discussion revolved around the above points and stressed on sustainable packaging.

The discussion started with packaging material waste management and how effectively is the pharma industry handling it? Commenting on it, Shivaji Chakraborty quoted a 2015 Survey by a UK-based agency where it was revealed that out of 6.5 tonnes of packaging material of waste only 12 per cent material was recycled and rest was dumped into the sea. He mentioned that due to lack of recycling, the environment is getting polluted more and the situation is getting worse.

Tripti Nakhare, while throwing light on the present scenario, said that India has already started looking at recycling packaging waste. She mentioned about a notification which is already in place for plastic and PET bottles, wherein, manufacturers are expected to mention a recyclable price which they will get when they will return the bottle back to buyers. According her, a number of polythene bag manufacturers have implemented this move.  Nakhare also informed about the latest regulations of EU – FMD for tamper evidence packaging and emphasised on the need to evaluate each aspect of tamper evidence features to comply with regulations such as EU-FMD. While informing about the features, she briefed that it is a combination of safety requirements on the pack along with tamper evidence. According to her,  all this has evolved because of a secure supply chain which in turn helps patients to get genuine, authentic quality packed medicines.

Following this, Chandi Prasad commented on the reasons why pharma companies cannot get away with plastics? He emphasised on optimum and minimum sized packs where companies will be able to reduce packaging waste considerably and these can be done by using packaging technologies. Panelists also talked about the importance of labelling and how pharma companies are providing information through them. Panel members touched upon regulatory changes which are meant for betterment of the industry and opined that experts’ views should be taken into account before implementing any regulation. Citing an example, panelists pointed out how Indian labelling market has changed drastically and four to five new GSRs have released recently. The panelists also felt that regulations over the last five years have changed immensely and have become very stringent. They were of the opinion that companies should constantly evolve and enhance their systems and processes to ensure regulatory compliance. They concluded that as the pharma industry undergoes a revolution driven by technology and digitalisation, there is more transparency of the processes and protocols followed at each level.


There is a need to evaluate each aspect of tamper evidence features to comply with regulations such as EU-FMD

Tripti Nakhare, Sr General Manager, Regulatory Affairs & PDD, FDC


There is going to be intense pressure on pharma companies to reduce spurious packaging material and pharma packaging will have tremen dous growth in the coming  years

Mohan Joshi, Management Consultant (Moderator)


The government should consider making some provisions of putting brand names of pharma companies as legibility of text especially on the blister pack is very less

Shivaji Chakraborty, Asst.General Manager, Fresenius Kabi Oncology


Tamper evidence feature is as simple as it looks and companies cannot change complete packaging lines as it involves considerable investment, study, validation and various mechanism

Chandiprasad Ravipati, Head-Packaging, Aurobindo Pharma

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