The recent unearthing of expired drugs in Tamil Nadu has not only highlighted the necessity of a common incineration plant to destroy the drugs recalled from circulation, but also reinforced the need for proper storage facilities in pharmacies and in stockists' godowns as specified in the Schedule P of the D&C Act.
When the Tamil Nadu branch of the Indian Pharmaceutical Association has extended its support to the state government for establishing an incineration plant, the enforcement agencies of the government are serious on tightening regulations on the drug delivery system in the country with special focus on maintenance of storage conditions in pharmacies.
According to sources from the drugs control department, if a drug is to be sustained it should be stored in proper storage conditions. The department has strictly informed all the pharma wholesalers and retail outlets to maintain refrigerated godowns and air-conditioned rooms to keep the potency of the drugs.
In a recently held meeting of manufacturers organized by IPA in Chennai, the deputy director of Drugs Control MM Yousuf said the industry and the regulatory bodies are responsible to maintain the cold-chain management till the drug is reached the patients, the ultimate user. Good refrigerator, back-up generator / inverter and air-conditioner have to set up with the pharmacy stores in order to maintain the prescribed temperature always.
He said if the polio vaccine is not stored in a proper storage condition, it may give false hope to the people and children may develop polio in due course. So everyone involved in the business of drugs should give importance to storage maintenance because so as to give therapeutic efficacy to the drug. Like quality assurance, quality release of the medicine assumes vital role, whose responsibility is on the traders. According to him, vaccines are very sensitive drugs and if a small change in temperature occurs to them, the efficacy will be lost.
"Cold storage is an unnoted area, but plays a vital role in the efficacy of medicines. All the manufacturing units, retail shops and distributors' stores have to develop this facility. The need of the hour is to put up centralized AC in all the medical stores. All the government hospitals in Tamil Nadu, the pharmacies are following the rules," he said. The state health department ensures proper preservation of drugs as specified in the Act, he added.
It is learnt that the health department will shortly organize a meeting of office-bearers of the associations of manufacturers, distributors and retailers to discuss the issues and find solutions for the burning issues. The Tamil Nadu IPA has already approached the government with full support to establish a Common Expiry Processing Unit with men and machinery. If it is materialized, Tamil Nadu will be the model state to establish such a facility for a good purpose.
According to sources, there are 42500 pharmacies working in the state and 1000 manufacturing and marketing companies. For the smooth conduct of inspections, the government has recently appointed 25 drugs inspectors and process of filling up another 25 is on.
When the Tamil Nadu branch of the Indian Pharmaceutical Association has extended its support to the state government for establishing an incineration plant, the enforcement agencies of the government are serious on tightening regulations on the drug delivery system in the country with special focus on maintenance of storage conditions in pharmacies.
According to sources from the drugs control department, if a drug is to be sustained it should be stored in proper storage conditions. The department has strictly informed all the pharma wholesalers and retail outlets to maintain refrigerated godowns and air-conditioned rooms to keep the potency of the drugs.
In a recently held meeting of manufacturers organized by IPA in Chennai, the deputy director of Drugs Control MM Yousuf said the industry and the regulatory bodies are responsible to maintain the cold-chain management till the drug is reached the patients, the ultimate user. Good refrigerator, back-up generator / inverter and air-conditioner have to set up with the pharmacy stores in order to maintain the prescribed temperature always.
He said if the polio vaccine is not stored in a proper storage condition, it may give false hope to the people and children may develop polio in due course. So everyone involved in the business of drugs should give importance to storage maintenance because so as to give therapeutic efficacy to the drug. Like quality assurance, quality release of the medicine assumes vital role, whose responsibility is on the traders. According to him, vaccines are very sensitive drugs and if a small change in temperature occurs to them, the efficacy will be lost.
"Cold storage is an unnoted area, but plays a vital role in the efficacy of medicines. All the manufacturing units, retail shops and distributors' stores have to develop this facility. The need of the hour is to put up centralized AC in all the medical stores. All the government hospitals in Tamil Nadu, the pharmacies are following the rules," he said. The state health department ensures proper preservation of drugs as specified in the Act, he added.
It is learnt that the health department will shortly organize a meeting of office-bearers of the associations of manufacturers, distributors and retailers to discuss the issues and find solutions for the burning issues. The Tamil Nadu IPA has already approached the government with full support to establish a Common Expiry Processing Unit with men and machinery. If it is materialized, Tamil Nadu will be the model state to establish such a facility for a good purpose.
According to sources, there are 42500 pharmacies working in the state and 1000 manufacturing and marketing companies. For the smooth conduct of inspections, the government has recently appointed 25 drugs inspectors and process of filling up another 25 is on.
Posts
No comments:
Post a Comment