The Indian Drug Manufacturers’ Association (IDMA) has written to the ministry of health and family welfare and the PMO, slamming the proposed ban on using plastic containers as primary packaging of drugs and formulations in the country, according to the letters examined by FE.

The draft rules issued on September 29 proposes to ban PET packaging for drugs used to treat children, elderly, pregnant women and women of reproductive age group. The proposal was a result of petitions by HIM Jagruti, a non-profit outfit, who said plastic bottles leach toxins in extreme temperatures and if stored for long, may cause cancer and physical infirmities.

The pharmaceutical companies were given 45 days to respond to the proposed changes and the companies have provided a joint reply in the form of the IDMA letter, according to an executive in a domestic pharmaceutical company.

The Drugs Technical Advisory Board (DTAB) had initially considered banning the use of plastic during a meeting held on November 25, 2013. The IDMA, in turn, had made a detailed submission on December 20, 2013, asking them to reconsider the recommendation.

The IDMA, in its letters, quoted the finding of an expert committee set up by DTAB to study the health-related claims noted that, “information provided in the representation of the NGO and according to available literature, is not sufficient enough to establish a definite correlation of causality of plastic container for pharmaceutical products and adverse health effects.”

With a total pharmaceutical-specific market of 1 lakh metric ton or Rs 2,500 crore, the plastic industry is up in arms against the proposal, saying there is no precedence for such a move. However, the pharmaceutical companies have now joined the issue, allying itself with the plastic industry.

“Transportation costs and packaging costs of corrugated boxes will drastically increase due to increased weight of glass bottles and during transport breakages will add to the costs,” the IDMA letter said. The industry body said it expects an increase of 25% to 30% in costs per bottle, which will in turn push up drug prices. The letter also said supply will not be able to meet the increased demand for glass bottles and may lead to shortages.

“The pharma industry does use glass bottles in certain instances where amber colored containers are required to protect the medicine from being exposed to UV light. However, there is already an acute shortage of raw materials needed for glass and hence manufacturers of glass bottles may not be able to meet requirements,” the IDMA letter said.

The glass manufacturing companies said in a press conference held in Mumbai on Thursday that the contentions are not true.
“Glass industry in India has a capacity of over 10,000 tons of glass per day which will convert to yearly capacity of almost 3.7 million tonnes and in terms of requirement if it is required immediately we have capacity of over 1 million tonnes, which is more than sufficient to cater to the requirement,” said Sanjay Tiwari, chief operating officer of Piramal Glass.

“Our main concern is the damages,” said an executive at a leading pharmaceutical company. “In-house estimates pegs costs to rise by 10% and pricing will be adjusted accordingly, but the main issue is the durability of the packaging. There will be a lot of breakage and returns and wasted medicine.”

He added that studies cited for the basis of the change in rules are all based in western countries but authorities in those countries have not made any move to ban PET packaging. The organisers of the press conference on Thursday, a collective known as Act India, said that proposals have been mooted in Europe and USA.