Times of India
03 April 2010
By Vivek Narayanan

With Drugs And Cosmetics Act Not Clear On How To Destroy Expired Medicines, Racketeers Find It Easy To Procure Them
The unearthing of the expired drugs racket in the city has brought to focus the lack of incinerators and proper documentation of destruction of drugs. Pharma experts feel poor monitoring of the expired drug destruction by manufacturers is at the centre of the problem. They also feel a drug destruction protocol should be included in the Drugs and Cosmetics Act.

Drugs control inspectors and TOI investigation have revealed largescale recycling of expired drugs collected by agents from dump yards, besides pharma company drivers assigned to destroy the drugs at the yards. According to pharma industry sources, the industry in the state is worth Rs 4,800 crore and expired drugs constitute at least 5% of this.

If a drug expires at the retail shop it has to be returned to the stockist who hands it over to the manufacturer. If the medicine is returned within six months after expiry, then the whole amount for which it was purchased is returned.

The manufacturer has to destroy the medicine preferably using an incinerator. A receipt which contains the date of destruction, value of goods and the name of the company representative who was present during the destruction process has to be provided by the party which carried out the destruction.

“It is a fact that we don’t have enough incinerators,” said state drugs control director M Bhasakaran.

“There are no clear rules in the Drugs and Cosmetics Act on how to destroy expired medicines. But the common practice is to incinerate them. There are no sufficient incinerators in the city, so the manufacturers take the drugs to a private incinerator in Singaperumal Koil and destroy them,” said a source.

He said the state health department could also create an incinerator, making it mandatory for destruction only at the approved sites. A destruction report should be filed by the manufacturers or distributors with the Drugs control on a monthly basis.

Sources in the pharma industry also suspect that a carting agent who serves as a bridge between the manufacturing company and incineration centre could be responsible for the circulation of expired drugs. Meanwhile, Chennai Corporation commissioner Rajesh Lakhoni said that the local body would take action against those pharma companies who dump waste in the street bins meant for solid waste. Also, the corporation will not encourage outsiders to use the notified dumping ground. “The local body itself has recently outsourced incineration of medical waste from civic bodyrun hospitals,” he said.

The pharmaceutical waste is regulated as hazardous waste and must be managed differently than other solid waste. “Under the Hazardous Wastes (Management, Handling and Transboundary Movement)Amendment Rules, 2009, handling of hazardous waste like expired and discarded drugs should be done by state pollution control boards,” says Gopal Krishna of Toxics Watch Alliance.

Retailers
Any unsold drugs past their date of expiry are labelled and kept apart and returned to the stockist. If the medicine is returned within six months after expiry, then the whole amount for which it was purchased is returned

Carting Agent
Carting agents then hand over drugs to the incinerator plant and obtain a certificate destruction.

Sources in the pharma industry also suspect that a carting agent who serves as a bridge between the manufacturing company and incineration centre could be responsible for the circulation of expired drugs. The agent is suspected of having a nexus with garbage dumping agents and would have sold the medicines to them

Incinerators
A receipt which contains the destruction date, value of goods, name of the company representative present during the destruction has to be given by the incineration centre

Manufacturer
The manufacturer supplies the medicine to the stockist for distribution to retail outlets across the city

Stockist/Sub–stockist
The drugs are then supplied to retailers for sale against prescription. Stockists take back the expired drugs from retailers and return them to the manufacturers and get the full amount for the medicine order reimbursed. The manufacturer has to destroy the medicine preferably using an incinerator.

Toothless Law

• No clear rules in the Drugs and Cosmetics Act on destruction of expired medicines.
• But the common practice is to burn them in an incinerator.
• The health department could establish an incineration facility, making it mandatory for destruction only at the approved sites.
• There aren’t sufficient incinerators in the city and suburbs, so most manufacturers take the medicines to a private incinerator in Singaperumal Koil and destroy them.