India bans plastic packaging for liquid pharmaceutical products

By Ajoy K Das

KOLKATA (ICIS)–India has imposed a ban on the use of plastic packaging for liquid pharmaceutical formulations, and the domestic pharmaceutical industry was given six months to make the switch to glass packaging, a government official said on Tuesday.

According to players in the domestic plastics industry, it is too early to assess the loss of business from this newly implemented regulation.

In a notification issued on 19 October, India’s Ministry of Health said: “No pharmaceutical manufacturer shall use PET or plastic containers for packing liquid oral formulations for primary packaging of drug formulations for use by pediatric, geriatric and women of reproductive age.”

The Indian pharmaceutical packaging material industry is valued at around $23bn and is growing at annualized rate of 15%. The polyethylene terephthalate (PET) bottle industry used for packing beverages and pharmaceuticals was estimated at $1.6bn and, prior to the ban, was forecast to grow to $2.15bn by 2016.

The ban on plastic bottles for pharmaceutical use was imposed upon the recommendation of the country’s Drug Technical Advisory Board (DTAB) early this month.

India had started looking into the adverse effects of using PET in pharmaceutical packaging in early 2013.

Several representations were made before the health ministry and DTAB on health hazards of using polyethylene terephthalate (PET) bottles for packing liquid medications such as suspensions and syrups.

Drug manufacturers represented by bodies like Goa Pharmaceutical Manufacturers Association (GPMA) had argued that PET was widely used in as packaging material for pharmaceutical products even in high developed and regulated markets like UK, US and Japan.

But it was established that plastic packaging has an adverse effect on humans due to presence of endocrine disruptors, which refer to chemicals that can interfere with the hormone system, according to the health ministry official.

DTAB, in its report, concluded that Indian environmental conditions were very different from those in developed and regulated markets, and with temperatures rising to as high as 45-50 degree centigrade in most parts of the country, risks of degradation from use of plastic packaging was much higher, the ministry official said.

The pharmaceutical industry has been given six months from the date of the ministry notification to make the switch to glass bottles, which are more expensive than PET packaging, but ensures higher stability and efficacy of liquid formulations, the official said.

No such objections on the use of PET were raised on food packaging, the official said.

Read John Richardson and Malini Hariharan’s blog – Asian Chemical Connections